FDA 510(k) Application Details - K161432

Device Classification Name	Negative Pressure Wound Therapy Powered Suction Pump   More FDA Info for this Device
510(K) Number	K161432
Device Name	Negative Pressure Wound Therapy Powered Suction Pump
Applicant	Stortford Medical LLC 295 Princeton Hightstown Road, Unit 321 West Windsor, NJ 08550 US Other 510(k) Applications for this Company
Contact	Chris Daughtery 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	05/24/2016
Decision Date	02/08/2017
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