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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 K905021
Device Name ACETATE CONCENTRATES FOR HEMODIALYSIS
Applicant
MEDICAL COMPONENTS, INC.
1499 DELP DR.
HARLEYSVILLE,  PA  19438
Applicant Contact RACHEL D RICHARDSON
Correspondent
MEDICAL COMPONENTS, INC.
1499 DELP DR.
HARLEYSVILLE,  PA  19438
Correspondent Contact RACHEL D RICHARDSON
Regulation Number876.5820
Classification Product Code
KPO  
Date Received11/07/1990
Decision Date 03/15/1991
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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