The following data is part of a premarket notification filed by Medtronic Xomed with the FDA for Merogel Control Gel Ent Surgical Dressing.
| Device ID | K002972 |
| 510k Number | K002972 |
| Device Name: | MEROGEL CONTROL GEL ENT SURGICAL DRESSING |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | MEDTRONIC XOMED 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | Diana Preston |
| Correspondent | Diana Preston MEDTRONIC XOMED 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-22 |
| Decision Date | 2000-12-15 |