The following data is part of a premarket notification filed by 3m Company-3m Health Care with the FDA for 3m Attest 1491 Super Rapid Readout Biological Indicator; 3m Attest 490 Auto-reader.
| Device ID | K103277 |
| 510k Number | K103277 |
| Device Name: | 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | 3M COMPANY-3M HEALTH CARE 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55133 -1006 |
| Contact | Suzanne Leung |
| Correspondent | Suzanne Leung 3M COMPANY-3M HEALTH CARE 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55133 -1006 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-05 |
| Decision Date | 2011-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50707387763058 | K103277 | 000 |
| 50707387762952 | K103277 | 000 |