FDA 510(k) Application Details - K172140

Device Classification Name	More FDA Info for this Device
510(K) Number	K172140
Device Name	NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)
Applicant	PolyNovo Biomaterials Pty Ltd Unit 2, 320 Lorimer Street Port Melbourne 3207 AU Other 510(k) Applications for this Company
Contact	Sue Cho 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	07/17/2017
Decision Date	08/11/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review