K944025 is an FDA 510(k) clearance for the SURGICAL INSTRUMENT TRAY, a Tray, Surgical, Instrument (Class I — General Controls, product code FSM), submitted by Riley Medical, Inc. (North Attleboro, US). The FDA issued a Cleared decision on November 22, 1994, 97 days after receiving the submission on August 17, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K944025 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 17, 1994 |
| Decision Date | November 22, 1994 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FSM — Tray, Surgical, Instrument |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |