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FDA 510(k) Application Details - DEN230068
Device Classification Name
Indicator, Physical/Chemical Sterilization Process
More FDA Info for this Device
510(K) Number
DEN230068
Device Name
Indicator, Physical/Chemical Sterilization Process
Applicant
3M Company
3M Center
2510 Conway Ave., Building 275-5W-06
St. Paul, MN 55144 US
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Contact
Michelle Larsen
Other 510(k) Applications for this Contact
Regulation Number
880.2800
More FDA Info for this Regulation Number
Classification Product Code
JOJ
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More FDA Info for this Product Code
Date Received
09/29/2023
Decision Date
05/21/2024
Decision
DENG -
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
FDA Source Information for DEN230068
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