Spelna, Inc.
Mchenry, IL, US
Spelna, Inc. appears in FDA device records in Mchenry, IL. FDA records list 11 510(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
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Spelna, Inc. between 1982 and 1986. The busiest year on record is 1985, with 4. The most recent is 1986, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 2 |
| 1985 | 4 |
| 1986 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K852525 | SATALEC PIEZOTEC | ELC | Substantially Equivalent | |
| K852527 | SATALEC SEPTOSONIC SC 80/SC 120 | FLG | Substantially Equivalent | |
| K852522 | SATALEC SERVOTOME | EKZ | Substantially Equivalent | |
| K853200 | 5X2 SATALEC CHIROPODY CASE | Substantially Equivalent | ||
| K852524 | SATALEC SERVOTORQUE S2 SX2 | EIA | Substantially Equivalent | |
| K852521 | SATLEC PROPHY UNIT PU 3055 | KOJ | Substantially Equivalent | |
| K832674 | SATELEC PROPHY UNIT PU 2000S | ELC | Substantially Equivalent | |
| K832664 | SATELEC SUPRASSON PIEZOMATIC P2 | ELC | Substantially Equivalent | |
| K832673 | SATELEC PROPHY UNIT PU-2000 | EIA | Substantially Equivalent | |
| K832665 | SATELEC SUPRASSON SP 3055 | ELC | Substantially Equivalent | |
| K820256 | MEDILAC #SR4 & SR 40 | DSH | 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