FDA 510(k) Application Details - K082311

Device Classification Name	Negative Pressure Wound Therapy Powered Suction Pump   More FDA Info for this Device
510(K) Number	K082311
Device Name	Negative Pressure Wound Therapy Powered Suction Pump
Applicant	THE MEDICAL COMPANY P.O. BOX 2116 AMERSFOORT 3800 CC NL Other 510(k) Applications for this Company
Contact	HARM JAAP SMIT 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	08/13/2008
Decision Date	10/08/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	Y
Expedited Review