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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 K852764
Device Name IDECAP DIALYZER
Applicant
Trans-National Trade Development Corp.
2 Dag Hammarskjold Plz.
866 Second Ave.
New York,  NY  10017
Applicant Contact ROBERT KELLER
Correspondent
Trans-National Trade Development Corp.
2 Dag Hammarskjold Plz.
866 Second Ave.
New York,  NY  10017
Correspondent Contact ROBERT KELLER
Regulation Number876.5830
Classification Product Code
FJH  
Date Received06/28/1985
Decision Date 09/20/1985
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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