FDA 510(k) Application Details - K132936

Device Classification Name	Negative Pressure Wound Therapy Powered Suction Pump   More FDA Info for this Device
510(K) Number	K132936
Device Name	Negative Pressure Wound Therapy Powered Suction Pump
Applicant	POLYNOVO BIOMATERIALS PTY LTD 816 CONGRESS AVE. SUITE 1400 AUSTIN, TX 78701 US Other 510(k) Applications for this Company
Contact	Carrie Hetrick Other 510(k) Applications for this Contact
Regulation Number	878.4780   More FDA Info for this Regulation Number
Classification Product Code	OMP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/2013
Decision Date	03/04/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review