The following data is part of a premarket notification filed by American Medical Disposable, Inc. with the FDA for Non - Adherent Bandage.
| Device ID | K833733 |
| 510k Number | K833733 |
| Device Name: | NON - ADHERENT BANDAGE |
| Classification | Dressing, Wound, Drug |
| Applicant | AMERICAN MEDICAL DISPOSABLE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-25 |
| Decision Date | 1983-12-27 |