The following data is part of a premarket notification filed by American Medical Disposable, Inc. with the FDA for An Odor Absorbent Bandage.
| Device ID | K833735 |
| 510k Number | K833735 |
| Device Name: | AN ODOR ABSORBENT BANDAGE |
| Classification | Gauze / Sponge,nonresorbable For External Use |
| Applicant | AMERICAN MEDICAL DISPOSABLE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | NAB |
| CFR Regulation Number | 878.4014 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-25 |
| Decision Date | 1984-04-23 |