The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Attest Steam Chemical Integrators (1243a, 1243b, 1243re, 1243res).
| Device ID | K220942 |
| 510k Number | K220942 |
| Device Name: | 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | 3M Company 2510 Conway Avenue, Bldg. 275-5W-06 Saint Paul, MN 55144 -1000 |
| Contact | Yumi Wackerfuss |
| Correspondent | Yumi Wackerfuss 3M Company 2510 Conway Avenue, Bldg. 275-5W-06 Saint Paul, MN 55144 -1000 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-31 |
| Decision Date | 2022-06-24 |