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FDA 510(k) Application Details - K193254
Device Classification Name
Indicator, Physical/Chemical Sterilization Process
More FDA Info for this Device
510(K) Number
K193254
Device Name
Indicator, Physical/Chemical 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
JOJ
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More FDA Info for this Product Code
Date Received
11/26/2019
Decision Date
12/23/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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