The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Attest 290 Auto-reader.
| Device ID | K004009 |
| 510k Number | K004009 |
| Device Name: | 3M ATTEST 290 AUTO-READER |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | 3M COMPANY 5353 WAYZATA BLVD. SUITE 505 Minneapolis, MN 55416 |
| Contact | Stephan Norsted |
| Correspondent | Stephan Norsted 3M COMPANY 5353 WAYZATA BLVD. SUITE 505 Minneapolis, MN 55416 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-26 |
| Decision Date | 2002-03-25 |