FDA 510(k) Application Details - DEN230068

Device Classification Name Indicator, Physical/Chemical Sterilization Process

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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
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Regulation Number 880.2800

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Classification Product Code JOJ
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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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