FDA 510(k) Application Details - K161797

Device Classification Name	Negative Pressure Wound Therapy Powered Suction Pump   More FDA Info for this Device
510(K) Number	K161797
Device Name	Negative Pressure Wound Therapy Powered Suction Pump
Applicant	MOLNLYCKE HEALTH CARE, US LLC 5550 PEACHTREE PARKWAY SUITE 500 NORCROSS, GA 30092 US Other 510(k) Applications for this Company
Contact	MEGAN BEVILL 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	06/30/2016
Decision Date	10/19/2016
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