J.F. Jelenko & Co., Inc.
Armonk, NY, US
J.F. Jelenko & Co., Inc. appears in FDA device records in Armonk, NY. FDA records list 56 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 56
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 56FDA records hold 56 510(k) clearances for J.F. Jelenko & Co., Inc. between 1988 and 2001. The busiest year on record is 1993, with 13. The most recent is 2001, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 6 |
| 1992 | 7 |
| 1993 | 13 |
| 1994 | 5 |
| 1996 | 2 |
| 1997 | 5 |
| 1998 | 3 |
| 1999 | 6 |
| 2000 | 8 |
| 2001 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K012303 | JEL-20 | EJS | Substantially Equivalent | |
| K002993 | HERACERAM | EIH | Substantially Equivalent | |
| K002645 | JEL BIOS PURE | EJT | Substantially Equivalent | |
| K002222 | RD-2104 | EJT | Substantially Equivalent | |
| K001360 | SIGNUM | EBF | Substantially Equivalent | |
| K001260 | ALLROUND 55 LF | EJT | Substantially Equivalent | |
| K001196 | JEL BIOS 90 (CODE NAME RD-2401) | EJT | Substantially Equivalent | |
| K000532 | JEL 15 | EJS | Substantially Equivalent | |
| K000213 | JELDENT BASIC LINE | ELM | Substantially Equivalent | |
| K993152 | JEL BIOS 18 (CODE NAME RD- 1214) | EJT | Substantially Equivalent | |
| K993136 | JEL BIOS 10 (CODE NAME RD-1801) | EJT | Substantially Equivalent | |
| K991564 | JELTEMP | EBG | Substantially Equivalent | |
| K990056 | JELDENT MULTICRYL | EBI | Substantially Equivalent | |
| K984587 | ALLROUND-E (CODE NAME RD 1710) | EJS | Substantially Equivalent | |
| K984140 | MAINBOND A | EJT | Substantially Equivalent | |
| K981257 | JELFINE-52 (CODE NAME RD-0901) | EJS | Substantially Equivalent | |
| K981244 | BW-1 (CODE NAME RD-0807) | EJT | Substantially Equivalent | |
| K981247 | SILCAST (CODE NAME RD-0118) | EJS | Substantially Equivalent | |
| K973881 | PROSPECTOR PLUS (CODE NAME : RD-0508) | EJT | Substantially Equivalent | |
| K971575 | BENCHMARK-IV | EJT | Substantially Equivalent | |
| K971574 | JELBOND-PDF | EJT | Substantially Equivalent | |
| K971292 | JEL-71 PDF | EJT | Substantially Equivalent | |
| K970068 | JELENKO NO.1 (CODE NAME RD-0601) | EJT | Substantially Equivalent | |
| K960403 | DIAMOND (CODE NAME PT-054) | EJT | Substantially Equivalent | |
| K960399 | TOPAZ | EJT | Substantially Equivalent | |
| K944889 | ALLROUND 4 | EJT | Substantially Equivalent | |
| K944888 | MEDALIST | EJT | Substantially Equivalent | |
| K944887 | EUREKA PLUS | EJT | Substantially Equivalent | |
| K944679 | JEL 96 | EJT | Substantially Equivalent | |
| K933623 | EUREKA | EJT | Substantially Equivalent | |
| K932130 | FREEDOM PLUS (CODE NAME MISC-LIB-013) | EJT | Substantially Equivalent | |
| K930601 | FREEDOM | EJT | Substantially Equivalent | |
| K923717 | JELENKO PORCELAIN SYSTEM PVS PROCELAIN | EIH | Substantially Equivalent | |
| K923714 | SYMPHONY | EJT | Substantially Equivalent | |
| K923817 | ULTRAGOLD | EJT | Substantially Equivalent | |
| K923722 | HN-40 | EJT | Substantially Equivalent | |
| K923721 | PROSPECTOR | EJT | Substantially Equivalent | |
| K923720 | SUNCAST | EJT | Substantially Equivalent | |
| K923719 | SUNCAST D-KF | EJT | Substantially Equivalent | |
| K923718 | HP-3 | EJT | Substantially Equivalent | |
| K923716 | JEL-0-75 | EJT | Substantially Equivalent | |
| K923715 | SUNCAST-D | EJT | Substantially Equivalent | |
| K923713 | MICROSTAR | EJT | Substantially Equivalent | |
| K922774 | COLLEGIATE | EJT | Substantially Equivalent | |
| K922451 | LEGACY-XT | EJS | Substantially Equivalent | |
| K922450 | BENCHMARK C | EJS | Substantially Equivalent | |
| K922449 | PA-400 | EJS | Substantially Equivalent | |
| K922448 | BENCHMARK I | EJS | Substantially Equivalent | |
| K922447 | BENCHMARK III | EJS | Substantially Equivalent | |
| K922446 | ACCU-STAR | EJS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain