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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dialysate concentrate for hemodialysis (liquid or powder)
510(k) Number K800624
Device Name LOW-ACETATE HEMODIALYSIS BATH CONCENTR.
Applicant
TRAVENOL LABORATORIES, S.A.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TRAVENOL LABORATORIES, S.A.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5820
Classification Product Code
KPO  
Date Received03/19/1980
Decision Date 07/14/1980
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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