FDA 510(k) Application Details - DEN210055

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN210055
Device Name	The N-SWEAT Patch
Applicant	Candesant Biomedical, Inc. 3145 Geary Blvd., Suite 711 San Francisco, CA 94118 US Other 510(k) Applications for this Company
Contact	Scott A. Wilson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QVX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/2021
Decision Date	04/07/2023
Decision	DENG -
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review