The following data is part of a premarket notification filed by Info-chem with the FDA for Steam Sterilization Indicator.
| Device ID | K771080 |
| 510k Number | K771080 |
| Device Name: | STEAM STERILIZATION INDICATOR |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | INFO-CHEM 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 | 1977-06-15 |
| Decision Date | 1977-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50707387457032 | K771080 | 000 |
| 50707387469080 | K771080 | 000 |
| 50707387469073 | K771080 | 000 |