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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dialyzer, capillary, hollow fiber
510(k) Number K982337
Device Name CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER
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
FJI  
Date Received07/06/1998
Decision Date 12/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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