The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Attest Super Rapid 5 Steam-plus Challenge Pack.
| Device ID | K193154 |
| 510k Number | K193154 |
| Device Name: | 3M Attest Super Rapid 5 Steam-Plus Challenge Pack |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | 3M Company Bldg. 275-5W-06 St. Paul, MS 55144 |
| Contact | Mary Fretland |
| Correspondent | Mary Fretland 3M Company Bldg. 275-5W-06 St. Paul, MS 55144 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-14 |
| Decision Date | 2020-02-07 |