FDA 510(k) Application Details - K081047

Device Classification Name	Apparatus, Suction, Ward Use, Portable, Ac-Powered   More FDA Info for this Device
510(K) Number	K081047
Device Name	Apparatus, Suction, Ward Use, Portable, Ac-Powered
Applicant	DORNOCH MEDICAL SYSTEMS, INC. 4032 WEST RIVERSIDE ST. RIVERSIDE, MO 64150 US Other 510(k) Applications for this Company
Contact	ANTHONY MARTINI 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	04/14/2008
Decision Date	04/29/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review