FDA 510(k) Application Details - K142879

Device Classification Name	More FDA Info for this Device
510(K) Number	K142879
Device Name	BTM Wound Dressing
Applicant	POLYNOVO BIOMATERIALS PTY LTD UNIT 2, 320 LORIMER STREET PORT MELBOURNE 3207 AU Other 510(k) Applications for this Company
Contact	Philip Powell Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/02/2014
Decision Date	12/23/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review