FDA 510(k) Application Details - DEN160037

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN160037
Device Name	dermaPACE System
Applicant	SANUWAVE, INC. 11475 GREAT OAKS WAY, STE 150 ALPHARETTA, GA 30022 US Other 510(k) Applications for this Company
Contact	PETER STEGAGNO Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2016
Decision Date	12/28/2017
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