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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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