The following data is part of a premarket notification filed by Medical Action Industries, Inc. with the FDA for Burn Dressing.
| Device ID | K923846 |
| 510k Number | K923846 |
| Device Name: | BURN DRESSING |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| Applicant | MEDICAL ACTION INDUSTRIES, INC. 1934 NEW HWY. Farmingdale, NY 11735 |
| Contact | Stephen T Woody |
| Correspondent | Stephen T Woody MEDICAL ACTION INDUSTRIES, INC. 1934 NEW HWY. Farmingdale, NY 11735 |
| 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 | 1992-07-31 |
| Decision Date | 1992-09-11 |