The following data is part of a premarket notification filed by Surgicot, Inc. with the FDA for Assert Eo Biological Test Pack.
| Device ID | K854631 |
| 510k Number | K854631 |
| Device Name: | ASSERT EO BIOLOGICAL TEST PACK |
| 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 | 1985-11-18 |
| Decision Date | 1986-05-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995023888 | K854631 | 000 |
| 10724995023871 | K854631 | 000 |