FDA 510(k) Application Details - K093915

Device Classification Name	Clamp, Tubing, Blood, Automatic   More FDA Info for this Device
510(K) Number	K093915
Device Name	Clamp, Tubing, Blood, Automatic
Applicant	DEKA RESEARCH & DEVELOPMENT CORP. 340 COMMERCIAL ST. MANCHESTER, NH 03101-1108 US Other 510(k) Applications for this Company
Contact	ROBERT SWAIN Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FIG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2009
Decision Date	08/23/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review