FDA 510(k) Application Details - K052797

Device Classification Name	Apparatus, Exhaust, Surgical   More FDA Info for this Device
510(K) Number	K052797
Device Name	Apparatus, Exhaust, Surgical
Applicant	MEDTEK DEVICES, INC. 595 COMMERCE DR. AMHERST, NY 14228 US Other 510(k) Applications for this Company
Contact	ROBERT O DEAN Other 510(k) Applications for this Contact
Regulation Number	878.5070   More FDA Info for this Regulation Number
Classification Product Code	FYD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/03/2005
Decision Date	02/13/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review