The following data is part of a premarket notification filed by American Medical Disposable, Inc. with the FDA for Breathable Overwray Bandage Non-elas.
| Device ID | K833731 |
| 510k Number | K833731 |
| Device Name: | BREATHABLE OVERWRAY BANDAGE NON-ELAS |
| Classification | Tape And Bandage, Adhesive |
| Applicant | AMERICAN MEDICAL DISPOSABLE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-25 |
| Decision Date | 1984-01-27 |