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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K002235
Device Name HORIZONS ERCP CANNULA
Applicant
Horizons Intl. Corp.
200 Politecnica St.
Villas Univ. P.O. Box 250435
Aguadilla,  PR  00604
Applicant Contact RAFIC SALEH
Correspondent
Horizons Intl. Corp.
200 Politecnica St.
Villas Univ. P.O. Box 250435
Aguadilla,  PR  00604
Correspondent Contact RAFIC SALEH
Regulation Number876.5010
Classification Product Code
FGE  
Date Received07/24/2000
Decision Date 01/23/2001
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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