FDA 510(k) Application Details - DEN160012

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN160012
Device Name	D2 Dressing
Applicant	Z-MEDICA, LLC 4 FAIRFIELD BOULEVARD WALLINGFORD, CT 06492 US Other 510(k) Applications for this Company
Contact	SHEILA K. WALLIN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2016
Decision Date	06/30/2017
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