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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 K862304
Device Name DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM
Applicant
CD MEDICAL, INC.
14620 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Applicant Contact ALBERT E JARVIS,PHD
Correspondent
CD MEDICAL, INC.
14620 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Correspondent Contact ALBERT E JARVIS,PHD
Regulation Number876.5820
Classification Product Code
FKQ  
Date Received06/17/1986
Decision Date 09/09/1986
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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