The following data is part of a premarket notification filed by Surgicot, Inc. with the FDA for Assert Tm Biological/chemical Indicator.
| Device ID | K855101 |
| 510k Number | K855101 |
| Device Name: | ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | SURGICOT, INC. 55 KENNEDY DR. Smithtown, NY 11787 |
| Contact | James R Brown |
| Correspondent | James R Brown SURGICOT, INC. 55 KENNEDY DR. Smithtown, NY 11787 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-23 |
| Decision Date | 1986-07-17 |