The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Attest Super Rapid Readout Steam Challenge Pack, 3m Attest Super Rapid 5 Steam-plus Chaallenge Pack, 3m Attest Auto-reader, 3m Attest Auto-reader.
| Device ID | K173519 |
| 510k Number | K173519 |
| Device Name: | 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader |
| 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 | 2017-11-14 |
| Decision Date | 2018-04-23 |
| Summary: | summary |