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FDA 510(k) Application Details - K123546
Device Classification Name
Indicator, Biological Sterilization Process
More FDA Info for this Device
510(K) Number
K123546
Device Name
Indicator, Biological Sterilization Process
Applicant
3M COMPANY
3M CENTER, BLDG. 275--05-W-06
ST. PAUL, MN 55144-1000 US
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Contact
SUZANNE LEUNG
Other 510(k) Applications for this Contact
Regulation Number
880.2800
More FDA Info for this Regulation Number
Classification Product Code
FRC
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More FDA Info for this Product Code
Date Received
11/19/2012
Decision Date
03/18/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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