The following data is part of a premarket notification filed by American Convertors Div., American Pharmaseal with the FDA for Val-u-wrap Csr Wrap.
| Device ID | K801569 |
| 510k Number | K801569 |
| Device Name: | VAL-U-WRAP CSR WRAP |
| Classification | Wrap, Sterilization |
| Applicant | AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-08 |
| Decision Date | 1980-07-28 |