FDA 510(k) Application Details - K182722

Device Classification Name	Negative Pressure Wound Therapy Powered Suction Pump   More FDA Info for this Device
510(K) Number	K182722
Device Name	Negative Pressure Wound Therapy Powered Suction Pump
Applicant	Genadyne Biotechnologies 16 Midland Ave Hicksville, NY 11801 US Other 510(k) Applications for this Company
Contact	Swara Vashi 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	09/28/2018
Decision Date	09/27/2019
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