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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 K874549
Device Name NEPHROSS I.Q. ANDANTE
Applicant
ORGANON TEKNIKA CORP.
800 CAPITOLA DR.
DURHAM,  NC  27713
Applicant Contact SHELDON MAZURSKY
Correspondent
ORGANON TEKNIKA CORP.
800 CAPITOLA DR.
DURHAM,  NC  27713
Correspondent Contact SHELDON MAZURSKY
Regulation Number876.5820
Classification Product Code
FJI  
Date Received11/04/1987
Decision Date 01/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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