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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 K853591
Device Name DIALYZER, CAPILLARY, HOLLOW FIBER
Applicant
ORGANON TEKNIKA CORP.
5300 SOUTH PORTLAND AVE.
OKLAHOMA CITY,  OK  73119
Applicant Contact MARTIN ROBERTS
Correspondent
ORGANON TEKNIKA CORP.
5300 SOUTH PORTLAND AVE.
OKLAHOMA CITY,  OK  73119
Correspondent Contact MARTIN ROBERTS
Regulation Number876.5820
Classification Product Code
FJI  
Date Received08/27/1985
Decision Date 09/11/1985
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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