The following data is part of a premarket notification filed by American Convertors Div., American Pharmaseal with the FDA for Disp. Fenestrated Surg. Drape Sheets.
| Device ID | K802359 |
| 510k Number | K802359 |
| Device Name: | DISP. FENESTRATED SURG. DRAPE SHEETS |
| Classification | Drape, Surgical |
| Applicant | AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-26 |
| Decision Date | 1980-10-31 |