The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Attest Rapid Readout Steam Process Challenge Device, Model 1296v, 3m Attest Rapid Readout Steam-plus.
| Device ID | K101910 |
| 510k Number | K101910 |
| Device Name: | 3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55144 -1000 |
| Contact | Suzanne Leung |
| Correspondent | Suzanne Leung 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55144 -1000 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-09 |
| Decision Date | 2010-12-08 |
| Summary: | summary |