The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Merocel Instrument Wipe.
| Device ID | K791736 |
| 510k Number | K791736 |
| Device Name: | MEROCEL INSTRUMENT WIPE |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| Applicant | XOMED, INC. 8641 Baypine Road Jacksonville, FL 32216 |
| Contact | Don Bruce |
| Correspondent | Don Bruce XOMED, INC. 8641 Baypine Road Jacksonville, FL 32216 |
| Product Code | GER |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-31 |
| Decision Date | 1979-09-19 |