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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K213809
Device Name 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader
Applicant
3M Company
3m Center
2510 Conway Ave., Bldg. 275-5w-06
St. Paul,  MN  55144
Applicant Contact Hilary Hovde
Correspondent
3M Company
3m Center
2510 Conway Ave., Bldg. 275-5w-06
St. Paul,  MN  55144
Correspondent Contact Hilary Hovde
Regulation Number880.2800
Classification Product Code
FRC  
Date Received12/06/2021
Decision Date 04/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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