FDA 510(k) Application Details - K090759

Device Classification Name	Apparatus, Suction, Ward Use, Portable, Ac-Powered   More FDA Info for this Device
510(K) Number	K090759
Device Name	Apparatus, Suction, Ward Use, Portable, Ac-Powered
Applicant	BIODRAIN MEDICAL, INC. 2060 CENTRE POINTE BLVD SUITE 7 MENDOTA HEIGHTS, MN 55120-1269 US Other 510(k) Applications for this Company
Contact	CHAD RUWE Other 510(k) Applications for this Contact
Regulation Number	878.4780   More FDA Info for this Regulation Number
Classification Product Code	JCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/23/2009
Decision Date	04/01/2009
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	Y
Expedited Review