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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 skin patch for treatment of hyperhidrosis
De Novo Number DEN210055
Device Name The N-SWEAT Patch
Requester
candesant biomedical, inc.
3145 geary blvd., suite 711
san francisco,  CA  94118
Contact scott a. wilson
Regulation Number878.4425
Classification Product Code
QVX  
Date Received12/03/2021
Decision Date 04/07/2023
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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