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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K844185
Device Name MODIFIED C-DAK
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
KOC  
Date Received10/29/1984
Decision Date 01/03/1985
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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