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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, central multiple patient
510(k) Number K842058
Device Name HEMODIALYSIS BATH CONCENTRATE SOLUTION
Applicant
PHARMACEUTICAL DEVELOPMENT SYSTEMS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
PHARMACEUTICAL DEVELOPMENT SYSTEMS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5820
Classification Product Code
FKQ  
Date Received05/22/1984
Decision Date 07/26/1984
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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