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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 K910319
Device Name ACID CONCENTRATE SOLUTIONS
Applicant
BIOPHARM, INC.
C/O MEDICAL COMPONENTS, INC.
1499 DELP DRIVE
HARLEYSVILLE,  PA  19438
Applicant Contact RACHEL D RICHARDSON
Correspondent
BIOPHARM, INC.
C/O MEDICAL COMPONENTS, INC.
1499 DELP DRIVE
HARLEYSVILLE,  PA  19438
Correspondent Contact RACHEL D RICHARDSON
Regulation Number876.5820
Classification Product Code
KPO  
Date Received01/24/1991
Decision Date 04/24/1991
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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