The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for Attest Brand Rapid Readout Biological Ind. #129x.
| Device ID | K926364 |
| 510k Number | K926364 |
| Device Name: | ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
| Contact | Marvin L Hart |
| Correspondent | Marvin L Hart 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-22 |
| Decision Date | 1995-03-31 |