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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 K121593
FOIA Releasable 510(k) K121593
Device Name 3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK
Applicant
3M COMPANY
3M CENTER, BLDG. 275-5W-06
ST. PAUL,  MN  55144 -1000
Applicant Contact SUZANNE LEUNG
Correspondent
3M COMPANY
3M CENTER, BLDG. 275-5W-06
ST. PAUL,  MN  55144 -1000
Correspondent Contact SUZANNE LEUNG
Regulation Number880.2800
Classification Product Code
FRC  
Date Received05/31/2012
Decision Date 03/15/2013
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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