FDA 510(k) Application Details - K212022

Device Classification Name

  More FDA Info for this Device
510(K) Number K212022
Device Name 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
Applicant 3M Company
3M Center, Building 275-5W-06
St. Paul, MN 55144 US
Other 510(k) Applications for this Company
Contact Mary Fretland
Other 510(k) Applications for this Contact
Regulation Number

  More FDA Info for this Regulation Number
Classification Product Code QKM
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 06/29/2021
Decision Date 04/20/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact