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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 Dr.
Harleysville,  PA  19438
Applicant Contact RACHEL D RICHARDSON
Correspondent
Biopharm, Inc.
C/O Medical Components, Inc.
1499 Delp Dr.
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
Predetermined Change
Control Plan Authorized		 No
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