The following data is part of a premarket notification filed by 3m Company with the FDA for Attest Brand Rapid Readout Biological Indicator.
Device ID | K900771 |
510k Number | K900771 |
Device Name: | ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR |
Classification | Indicator, Biological Sterilization Process |
Applicant | 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
Contact | Marvin L Hart |
Correspondent | Marvin L Hart 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
Product Code | FRC |
CFR Regulation Number | 880.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-20 |
Decision Date | 1990-07-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50707387140934 | K900771 | 000 |