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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Dialysate Delivery, Central Multiple Patient
510(k) Number K844748
Device Name NEPHROSS ALLEGRO H.F.
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
FKQ  
Date Received12/06/1984
Decision Date 01/22/1985
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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