The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Merogel Nasal Dressing And Sinus Stent.
| Device ID | K982731 |
| 510k Number | K982731 |
| Device Name: | MEROGEL NASAL DRESSING AND SINUS STENT |
| Classification | Balloon, Epistaxis |
| 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 | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-05 |
| Decision Date | 1999-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033549790967 | K982731 | 000 |
| 08033549790950 | K982731 | 000 |
| 08033549790721 | K982731 | 000 |
| 08033549790714 | K982731 | 000 |
| 08033549791124 | K982731 | 000 |
| 08033549791117 | K982731 | 000 |