K760570 is an FDA 510(k) clearance for the ROBINSON MIDDLE EAR PROSTHESIS. This device is classified as a Syringe, Irrigating (dental) (Class I - General Controls, product code EIB).
Submitted by Xomed, Inc. (Arnold, US). The FDA issued a Cleared decision on September 21, 1976, 20 days after receiving the submission on September 1, 1976.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K760570 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1976 |
| Decision Date | September 21, 1976 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EIB — Syringe, Irrigating (dental) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |