The following data is part of a premarket notification filed by Premium Plastics, Inc. with the FDA for Gent-l-kare Laceration Trays.
| Device ID | K950850 |
| 510k Number | K950850 |
| Device Name: | GENT-L-KARE LACERATION TRAYS |
| Classification | Wrap, Sterilization |
| Applicant | PREMIUM PLASTICS, INC. 465 WEST CERMAK RD. Chicago, IL 60616 |
| Contact | Gary Garbin |
| Correspondent | Gary Garbin PREMIUM PLASTICS, INC. 465 WEST CERMAK RD. Chicago, IL 60616 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-24 |
| Decision Date | 1995-03-14 |