K902828 is an FDA 510(k) clearance for the SUTURE REMOVAL TRAY. This device is classified as a Scissors, General, Surgical (Class I - General Controls, product code LRW).
Submitted by Orion Life Systems, Inc. (Wheeling, US). The FDA issued a Cleared decision on August 8, 1990, 41 days after receiving the submission on June 28, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K902828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | June 28, 1990 |
| Decision Date | August 08, 1990 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | LRW — Scissors, General, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |