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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 K152060
FOIA Releasable 510(k) K152060
Device Name 3M Attest Rapid Readout Biological Indicator 1295
Applicant
3M Company
3m Center, Bldg. 275-5w-06
St. Paul,  MN  55144
Applicant Contact MATT MORTENSEN
Correspondent
3M Company
3m Center, Bldg. 275-5w-06
St. Paul,  MN  55144
Correspondent Contact MATT MORTENSEN
Regulation Number880.2800
Classification Product Code
FRC  
Date Received07/24/2015
Decision Date 12/01/2015
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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