Premium Plastics, Inc.
Mchenry, IL, US
Premium Plastics, Inc. appears in FDA device records in Mchenry, IL. FDA records list 9 510(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
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Premium Plastics, Inc. between 1977 and 1995. The busiest year on record is 1995, with 3. The most recent is 1995, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1980 | 1 |
| 1985 | 1 |
| 1989 | 2 |
| 1994 | 1 |
| 1995 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K953226 | PULM O2 SUCTION CATHETER TRAYS | BSY | Substantially Equivalent | |
| K950851 | GENT-L-KARE TRACHEOSTOMY TRAYS | LRQ | Substantially Equivalent | |
| K950850 | GENT-L-KARE LACERATION TRAYS | FRG | Substantially Equivalent for Some Indications | |
| K943740 | ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY) | FMI | Substantially Equivalent | |
| K890107 | GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT | FRO | Unknown | |
| K893135 | GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER | JOL | Substantially Equivalent | |
| K850285 | GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY | KOD | Substantially Equivalent | |
| K800440 | STERILE SPONGE BOWLS | FNY | Substantially Equivalent | |
| K771448 | STERILE SUTURE REMOVAL KIT | KDD | 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