The following data is part of a premarket notification filed by 3m Company with the FDA for 3mtm Attesttm Super Rapid Steam Biological Indicator 1592, 3mtm Attesttm Super Rapid Steam Challenge Pack, 3mtm Attesttm Auto- Readers 490 And 490h.
| Device ID | K192550 |
| 510k Number | K192550 |
| Device Name: | 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 And 490H |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | 3M Company Bldg. 275-5W-06 St.paul, MN 55144 |
| Contact | Hilary B Hovde |
| Correspondent | Hilary B Hovde 3M Company Bldg. 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 | 2019-09-17 |
| Decision Date | 2020-06-05 |