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FDA 510(k) Application Details - K200766
Device Classification Name
Indicator, Biological Sterilization Process
More FDA Info for this Device
510(K) Number
K200766
Device Name
Indicator, Biological Sterilization Process
Applicant
3M Company
3M Center, Building 275-5W-06
St. Paul, MN 55144 US
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Contact
Mary Fretland
Other 510(k) Applications for this Contact
Regulation Number
880.2800
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Classification Product Code
FRC
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More FDA Info for this Product Code
Date Received
03/25/2020
Decision Date
07/02/2020
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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