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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, tubing, blood, with and without anti-regurgitation valve
510(k) Number K982340
Device Name EXTRACORPOREAL BLOOD CIRCUIT
Applicant
HAIDYLENA MEDICAL EGYPT
26, MAKRAM EBEID ST.
NASR CITY, CAIRO,  EG 11371
Applicant Contact SAMEH TAMIM
Correspondent
HAIDYLENA MEDICAL EGYPT
26, MAKRAM EBEID ST.
NASR CITY, CAIRO,  EG 11371
Correspondent Contact SAMEH TAMIM
Regulation Number876.5820
Classification Product Code
FJK  
Date Received07/06/1998
Decision Date 04/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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