IFH
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Solution, Zenker'S
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.4010
- Medical specialty
- Pathology
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ZENKERS SOLUTION (K842732) | E K Ind., Inc. | 1984-08-03 |
| VOLU-SOL ZENKERS FIXATIVE (K822127) | Volu Sol Medical Industries | 1982-08-05 |
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