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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, Disposable
510(k) Number K861646
Device Name BIO-CARB D16000, D16001, AND D17000
Applicant
Societe D' Analyses Bio-Pharmaceutiques,Inc.
P.O. Box 16598
Wedgwood Station
Fort Worth,  TX  76162
Applicant Contact HAMER ASSOC.
Correspondent
Societe D' Analyses Bio-Pharmaceutiques,Inc.
P.O. Box 16598
Wedgwood Station
Fort Worth,  TX  76162
Correspondent Contact HAMER ASSOC.
Regulation Number876.5830
Classification Product Code
FJH  
Date Received04/30/1986
Decision Date 08/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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