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 |