The following data is part of a premarket notification filed by American Convertors Div., American Pharmaseal with the FDA for Patient Care Disposable Infant Shirts.
| Device ID | K802998 |
| 510k Number | K802998 |
| Device Name: | PATIENT CARE DISPOSABLE INFANT SHIRTS |
| Classification | Bedding, Disposable, Medical |
| Applicant | AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KME |
| CFR Regulation Number | 880.6060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-25 |
| Decision Date | 1980-12-22 |