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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 K121484
Device Name 3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER
Original Applicant
3M COMPANY
3m center, bldg. 275-5w-06
st. paul,  MN  55144 -1000
Original Contact suzanne leung
Regulation Number880.2800
Classification Product Code
FRC  
Date Received05/18/2012
Decision Date 10/19/2012
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
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