ITN
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Splint, Denis Brown
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3675
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VIEWMATE SYSTEM (K071028) | Ep Medsystems | 2007-05-01 |
| Y.E.S. POWERED WHEELCHAIR, MODEL T200 (K032669) | Yeou Eir Shuen Machinery Co., Ltd. | 2003-11-12 |
| COUNTER-ROTATION SYSTEM (K821256) | The Langer Group | 1982-06-23 |
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