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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, single patient
510(k) Number K910215
Device Name DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST
Applicant
CD MEDICAL, INC.
14620 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Applicant Contact GORDON W ROBERTSON
Correspondent
CD MEDICAL, INC.
14620 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Correspondent Contact GORDON W ROBERTSON
Regulation Number876.5820
Classification Product Code
FKP  
Date Received01/17/1991
Decision Date 04/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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