The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Attest Super Rapid Readout Biological Indicator 1492v, 3m Attest Auto-reader 490, 3m Attest Auto-reader 490h.
| Device ID | K173437 |
| 510k Number | K173437 |
| Device Name: | 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | 3M Company 3M Center, Building 275-5w-06 St. Paul, MN 55144 |
| Contact | Hilary B. Hovde |
| Correspondent | Hilary B. Hovde 3M Company 3M Center, Building 275-5w-06 St. Paul, MN 55144 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-03 |
| Decision Date | 2018-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50707387791914 | K173437 | 000 |