FDA 510(k) Application Details - K100823

Device Classification Name	Negative Pressure Wound Therapy Powered Suction Pump   More FDA Info for this Device
510(K) Number	K100823
Device Name	Negative Pressure Wound Therapy Powered Suction Pump
Applicant	ACCURO MEDICAL PRODUCTS LLC 3879 EAST 120TH AVE SUITE 328 DENVER, CO 80233 US Other 510(k) Applications for this Company
Contact	TODD HUBBARD 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	03/24/2010
Decision Date	01/24/2011
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