FDA 510(k) Application Details - K162129

Device Classification Name	Negative Pressure Wound Therapy Powered Suction Pump   More FDA Info for this Device
510(K) Number	K162129
Device Name	Negative Pressure Wound Therapy Powered Suction Pump
Applicant	Smith & Nephew, Inc. 970 Lake Carillon Drive, Suite 300 St Petersburg, FL 33716 US Other 510(k) Applications for this Company
Contact	Laura Reynolds 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	08/01/2016
Decision Date	08/31/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review