The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Robinson Middle Ear Prosthesis.
| Device ID | K760570 |
| 510k Number | K760570 |
| Device Name: | ROBINSON MIDDLE EAR PROSTHESIS |
| Classification | Syringe, Irrigating (dental) |
| Applicant | XOMED, INC. 1318 LONEDELL RD. Arnold, MO 63010 |
| Product Code | EIB |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-09-01 |
| Decision Date | 1976-09-21 |