The following data is part of a premarket notification filed by Medtrax Industries, Inc. with the FDA for Sure-adapt Non-adhering Dressing.
| Device ID | K933966 |
| 510k Number | K933966 |
| Device Name: | SURE-ADAPT NON-ADHERING DRESSING |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| Applicant | MEDTRAX INDUSTRIES, INC. 1372 BENNETT DR. SUITE 156 Longwood, FL 32750 |
| Contact | Juan E Alana |
| Correspondent | Juan E Alana MEDTRAX INDUSTRIES, INC. 1372 BENNETT DR. SUITE 156 Longwood, FL 32750 |
| Product Code | GER |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-16 |
| Decision Date | 1993-10-28 |