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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 K103277
Device Name 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER
Applicant
3M COMPANY-3M HEALTH CARE
3M CENTER, BLDG. 275-5W-06
ST. PAUL,  MN  55133 -1006
Applicant Contact SUZANNE LEUNG
Correspondent
3M COMPANY-3M HEALTH CARE
3M CENTER, BLDG. 275-5W-06
ST. PAUL,  MN  55133 -1006
Correspondent Contact SUZANNE LEUNG
Regulation Number880.2800
Classification Product Code
FRC  
Date Received11/05/2010
Decision Date 04/19/2011
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
Recalls CDRH Recalls
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