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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 K853513
Device Name DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY
Applicant
Cd Medical, Inc.
14620 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact ALBERT E JARVIS
Correspondent
Cd Medical, Inc.
14620 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact ALBERT E JARVIS
Regulation Number876.5820
Classification Product Code
FKP  
Date Received08/21/1985
Decision Date 11/06/1985
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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