The following data is part of a premarket notification filed by American Convertors Div., American Pharmaseal with the FDA for Absorb Furn Sheet.
| Device ID | K820994 |
| 510k Number | K820994 |
| Device Name: | ABSORB FURN SHEET |
| Classification | Sheet, Burn |
| Applicant | AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL 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 | 1982-04-08 |
| Decision Date | 1982-05-13 |