The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Merogel Otologic Pack.
| Device ID | K001148 |
| 510k Number | K001148 |
| Device Name: | MEROGEL OTOLOGIC PACK |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | Dave Timlin |
| Correspondent | Dave Timlin 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 | 2000-04-10 |
| Decision Date | 2000-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033549791001 | K001148 | 000 |
| 08033549790776 | K001148 | 000 |