The following data is part of a premarket notification filed by Medtronic Xomed with the FDA for Merogel Injectable Bioresorbable Nasal Dressing And Sinus Stent And Otologic Gel.
| Device ID | K122434 |
| 510k Number | K122434 |
| Device Name: | MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL |
| Classification | Polymer, Ear, Nose And Throat, Synthetic, Absorbable |
| Applicant | MEDTRONIC XOMED 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | Antoine Kouchakjy |
| Correspondent | Antoine Kouchakjy MEDTRONIC XOMED 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Product Code | NHB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-10 |
| Decision Date | 2012-10-31 |
| Summary: | summary |