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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name insert, pump, blood
510(k) Number K854084
Device Name PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT
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
FKL  
Date Received10/07/1985
Decision Date 11/08/1985
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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