K950850 is an FDA 510(k) clearance for the GENT-L-KARE LACERATION TRAYS. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Premium Plastics, Inc. (Chicago, US). The FDA issued a Cleared decision on March 14, 1995, 18 days after receiving the submission on February 24, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K950850 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | February 24, 1995 |
| Decision Date | March 14, 1995 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |