The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Attest 293 Auto-reader, 3m Attest 293g Auto-reader.
| Device ID | K052128 |
| 510k Number | K052128 |
| Device Name: | 3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55144 -1000 |
| Contact | Cynthia Lamanrucciola |
| Correspondent | Cynthia Lamanrucciola 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-05 |
| Decision Date | 2005-08-16 |
| Summary: | summary |