FDA 510(k) Application Details - K161410

Device Classification Name	Negative Pressure Wound Therapy Powered Suction Pump   More FDA Info for this Device
510(K) Number	K161410
Device Name	Negative Pressure Wound Therapy Powered Suction Pump
Applicant	CARILEX MEDICAL, INC. No. 77, Keji 1st Rd., Guishan Dist. Taoyuan City 333 TW Other 510(k) Applications for this Company
Contact	Henry Kao 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	05/20/2016
Decision Date	10/13/2016
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