The following data is part of a premarket notification filed by American Convertors Div., American Pharmaseal with the FDA for Shield Disp. Patients Poncho Gowns.
| Device ID | K801570 |
| 510k Number | K801570 |
| Device Name: | SHIELD DISP. PATIENTS PONCHO GOWNS |
| Classification | Gown, Patient |
| Applicant | AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FYB |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-08 |
| Decision Date | 1980-07-28 |