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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Subsystem, Water Purification
510(k) Number K894106
Device Name DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST
Applicant
Cd Medical, Inc.
14620 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact MARIAN D HARDING
Correspondent
Cd Medical, Inc.
14620 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact MARIAN D HARDING
Regulation Number876.5665
Classification Product Code
FIP  
Date Received06/09/1989
Decision Date 11/08/1989
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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