FDA 510(k) Application Details - K181505

Device Classification Name	Negative Pressure Wound Therapy Powered Suction Pump   More FDA Info for this Device
510(K) Number	K181505
Device Name	Negative Pressure Wound Therapy Powered Suction Pump
Applicant	KCI USA, Inc. 6203 Farinon Drive San Antonio, TX 78249 US Other 510(k) Applications for this Company
Contact	Melanie Avila 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	06/07/2018
Decision Date	03/28/2019
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