The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Epifilm Otologic Lamina.
| Device ID | K982870 |
| 510k Number | K982870 |
| Device Name: | EPIFILM OTOLOGIC LAMINA |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | Roy Berens |
| Correspondent | Roy Berens XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-14 |
| Decision Date | 1998-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033549791032 | K982870 | 000 |
| 08033549791025 | K982870 | 000 |
| 08033549791018 | K982870 | 000 |
| 08033549791063 | K982870 | 000 |