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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, sorbent regenerated
510(k) Number K882428
Device Name REDY 2000
Applicant
ORGANON TEKNIKA CORP.
100 AKZO AVE.
DURHAM,  NC  27712
Applicant Contact SHELDON MAZURSKY
Correspondent
ORGANON TEKNIKA CORP.
100 AKZO AVE.
DURHAM,  NC  27712
Correspondent Contact SHELDON MAZURSKY
Regulation Number876.5600
Classification Product Code
FKT  
Date Received06/13/1988
Decision Date 10/25/1988
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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