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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 K801385
Device Name K1 POTASSIUM ACETATE ADDITIVE
Applicant
ORGANON TEKNIKA CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ORGANON TEKNIKA CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5600
Classification Product Code
FKT  
Date Received06/13/1980
Decision Date 07/21/1980
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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