FDA 510(k) Application Details - K092992

Device Classification Name	Negative Pressure Wound Therapy Powered Suction Pump   More FDA Info for this Device
510(K) Number	K092992
Device Name	Negative Pressure Wound Therapy Powered Suction Pump
Applicant	GENADYNE BIOTECHNOLOGIES, INC. 1468 Harwell Avenue Crofton, MD 21114 US Other 510(k) Applications for this Company
Contact	E.J. Smith 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	09/28/2009
Decision Date	06/29/2010
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