FDA 510(k) Application Details - DEN150010

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN150010
Device Name	Dignitana AB DigniCap System
Applicant	DIGNITANA AB TRAKTORGRANDEN 3 LUND SE-226 60 SE Other 510(k) Applications for this Company
Contact	JAN RICHARDSSON Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PMC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/06/2015
Decision Date	12/08/2015
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