Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact