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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 K192550
Device Name 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H
Applicant
3M Company
Bldg.275-5w-06
St. Paul,  MN  55144
Applicant Contact Hilary B Hovde
Correspondent
3M Company
Bldg.275-5w-06
St. Paul,  MN  55144
Correspondent Contact Hilary B Hovde
Regulation Number880.2800
Classification Product Code
FRC  
Date Received09/17/2019
Decision Date 06/05/2020
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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