The following data is part of a premarket notification filed by American Convertors Div., American Pharmaseal with the FDA for Shield Disp. Reinforced Drape Sheets.
| Device ID | K800817 |
| 510k Number | K800817 |
| Device Name: | SHIELD DISP. REINFORCED DRAPE SHEETS |
| Classification | Drape, Surgical |
| Applicant | AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-11 |
| Decision Date | 1980-05-02 |