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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name indicator, physical/chemical sterilization process
De Novo Number DEN230068
Device Name 3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190
Requester
3m company
3m center
2510 conway ave., building 275-5w-06
st. paul,  MN  55144
Contact michelle larsen
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received09/29/2023
Decision Date 05/21/2024
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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