The following data is part of a premarket notification filed by Medtrax Industries, Inc. with the FDA for Plain Gauze Dressing.
| Device ID | K940692 |
| 510k Number | K940692 |
| Device Name: | PLAIN GAUZE DRESSING |
| Classification | Gauze/sponge, Internal |
| Applicant | MEDTRAX INDUSTRIES, INC. 1372 BENNETT DR. SUITE 156 Longwood, FL 32750 |
| Contact | Juan Alana |
| Correspondent | Juan Alana MEDTRAX INDUSTRIES, INC. 1372 BENNETT DR. SUITE 156 Longwood, FL 32750 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-16 |
| Decision Date | 1994-04-14 |