The following data is part of a premarket notification filed by American Medical Disposable, Inc. with the FDA for Temporary Burn Sheet With Perforated.
| Device ID | K792433 |
| 510k Number | K792433 |
| Device Name: | TEMPORARY BURN SHEET WITH PERFORATED |
| Classification | Sheet, Burn |
| Applicant | AMERICAN MEDICAL DISPOSABLE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPY |
| CFR Regulation Number | 880.5180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-28 |
| Decision Date | 1979-12-20 |