FDA 510(k) Application Details - K061367

Device Classification Name	Negative Pressure Wound Therapy Powered Suction Pump   More FDA Info for this Device
510(K) Number	K061367
Device Name	Negative Pressure Wound Therapy Powered Suction Pump
Applicant	BLUE SKY MEDICAL GROUP INCORPORATED 5924 BALFOUR CT. SUITE 102 CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	JASPER BENKE 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	05/16/2006
Decision Date	08/10/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review