FDA 510(k) Application Details - K982340

Device Classification Name	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve   More FDA Info for this Device
510(K) Number	K982340
Device Name	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Applicant	HAIDYLENA MEDICAL EGYPT 26, MAKRAM EBEID ST. NASR CITY, CAIRO 11371 EG Other 510(k) Applications for this Company
Contact	SAMEH TAMIM 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	07/06/1998
Decision Date	04/30/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review