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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Injection Needle, Gastroenterology-Urology
510(k) Number K010448
Device Name HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES
Applicant
Horizons Intl. Corp.
287 Monterrey St.
Ponce,  PR  00732
Applicant Contact RAFIC SALEH
Correspondent
Horizons Intl. Corp.
287 Monterrey St.
Ponce,  PR  00732
Correspondent Contact RAFIC SALEH
Regulation Number876.1500
Classification Product Code
FBK  
Date Received02/15/2001
Decision Date 05/16/2001
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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