The following data is part of a premarket notification filed by 3m Company with the FDA for 3m™ Attest™ Hydrogen Peroxide Indicator Tape 1228.
Device ID | K222152 |
510k Number | K222152 |
Device Name: | 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 |
Classification | Indicator, Physical/chemical Sterilization Process |
Applicant | 3M Company 2510 Conway Avenue, Bldg. 275-5W-06 St. Paul, MN 55144 -1000 |
Contact | Yumi Wackerfuss |
Correspondent | Yumi Wackerfuss 3M Company 2510 Conway Avenue, Bldg. 275-5W-06 St. Paul, MN 55144 -1000 |
Product Code | JOJ |
CFR Regulation Number | 880.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-07-20 |
Decision Date | 2022-09-23 |