510(k) DEN210055
- Device
- The N-SWEAT Patch
- Applicant
- Candesant Biomedical, Inc.
- 510(k) number
- DEN210055
- Product code
- QVX
- Decision
- Unknown (DENG)
- Decision date
- 2023-04-07
- Date received
- 2021-12-03
- Regulation
- 878.4425
- Classification name
- Skin Patch For Treatment Of Hyperhidrosis
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Scott A. Wilson
- Address
- 3145 Geary Blvd. Suite 711 San Francisco CA US 94118 94118
FDA Registration Numbers#
- 3007014520
Source Documents#
510(k) summary PDF not indicated by FDA