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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 K883068
Device Name HEMODIALYSIS CONCENTRATES
Applicant
DOVE MEDICAL SUPPLIES
315 GRAND BLVD.
VANCOUVER,  WA  98661
Applicant Contact DON CANNADY
Correspondent
DOVE MEDICAL SUPPLIES
315 GRAND BLVD.
VANCOUVER,  WA  98661
Correspondent Contact DON CANNADY
Regulation Number876.5820
Classification Product Code
KPO  
Date Received07/20/1988
Decision Date 12/22/1988
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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