The following data is part of a premarket notification filed by American Convertors Div., American Pharmaseal with the FDA for Iso-bac Instrument Wrap.
| Device ID | K802919 |
| 510k Number | K802919 |
| Device Name: | ISO-BAC INSTRUMENT 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 | 1980-11-18 |
| Decision Date | 1981-02-02 |