FDA 510(k) Application Details - K080341

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K080341
Device Name	Drape, Surgical
Applicant	VORTEK SURGICAL, LLC 1426 W. 29TH ST. SUITE 300 INDIANAPOLIS, IN 46208 US Other 510(k) Applications for this Company
Contact	THOMAS SZYMCZAK Other 510(k) Applications for this Contact
Regulation Number	878.4370   More FDA Info for this Regulation Number
Classification Product Code	KKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2008
Decision Date	07/21/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review