GEO
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- File, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GENERAL SURGICAL FILES (K844145) | Med-Tool, Inc. | 1984-11-20 |
| ORAL SPONGE (K830675) | Unisplint Corp. | 1983-03-24 |
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Every clearance here is in the API, with alerts when new ones post.