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 |