The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xomed Platinum Wire Teflon Pistion.
| Device ID | K872112 |
| 510k Number | K872112 |
| Device Name: | XOMED PLATINUM WIRE TEFLON PISTION |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | Gordon Peters |
| Correspondent | Gordon Peters XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-01 |
| Decision Date | 1987-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681490035521 | K872112 | 000 |
| 00681490035293 | K872112 | 000 |
| 00681490035286 | K872112 | 000 |
| 00681490035279 | K872112 | 000 |
| 00681490035262 | K872112 | 000 |
| 00681490035255 | K872112 | 000 |
| 00681490035248 | K872112 | 000 |
| 00681490035231 | K872112 | 000 |
| 00763000035426 | K872112 | 000 |
| 00763000035419 | K872112 | 000 |
| 00681490035309 | K872112 | 000 |
| 00681490035316 | K872112 | 000 |
| 00681490035514 | K872112 | 000 |
| 00681490035392 | K872112 | 000 |
| 00681490035385 | K872112 | 000 |
| 00681490035378 | K872112 | 000 |
| 00681490035361 | K872112 | 000 |
| 00681490035354 | K872112 | 000 |
| 00681490035347 | K872112 | 000 |
| 00681490035330 | K872112 | 000 |
| 00681490035323 | K872112 | 000 |
| 00763000035358 | K872112 | 000 |