The following data is part of a premarket notification filed by 3m with the FDA for 3mtm Attesttm Mini Auto-reader 490m.
| Device ID | K200092 |
| 510k Number | K200092 |
| Device Name: | 3MTM AttestTM Mini Auto-reader 490M |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | 3M 2510 Conway Ave, Bldg 275-5W-06 St. Paul, MN 55144 -1000 |
| Contact | Andrew Wingen |
| Correspondent | Andrew Wingen 3M 2510 Conway Ave, 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 | 2020-01-16 |
| Decision Date | 2020-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50707387790702 | K200092 | 000 |