The following data is part of a premarket notification filed by Amsco Co. with the FDA for Proof (biological/chemical Indicator).
| Device ID | K801109 |
| 510k Number | K801109 |
| Device Name: | PROOF (BIOLOGICAL/CHEMICAL INDICATOR) |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | AMSCO CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-12 |
| Decision Date | 1980-05-30 |