FDA 510(k) Application Details - K952631

Device Classification Name	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve   More FDA Info for this Device
510(K) Number	K952631
Device Name	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Applicant	B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. BETHLEHEM, PA 18018 US Other 510(k) Applications for this Company
Contact	MARK S ALSBERGE Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FJK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/08/1995
Decision Date	04/30/1996
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