The following data is part of a premarket notification filed by Surgicot, Inc. with the FDA for Surgicot 2 Indicator System.
| Device ID | K800029 |
| 510k Number | K800029 |
| Device Name: | SURGICOT 2 INDICATOR SYSTEM |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | SURGICOT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-07 |
| Decision Date | 1980-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995021464 | K800029 | 000 |
| 10724995021471 | K800029 | 000 |