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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Snare, Flexible
510(k) Number K083049
Device Name TORNADO ROTATABEL SNARE AND POLYP CATCHER
Applicant
Horizons Intl. Corp.
P.O. Box 213-3006
Zona Franca Metro
Barreal De Heredia,  CR
Applicant Contact RAFIC SALEH
Correspondent
Horizons Intl. Corp.
P.O. Box 213-3006
Zona Franca Metro
Barreal De Heredia,  CR
Correspondent Contact RAFIC SALEH
Regulation Number876.4300
Classification Product Code
FDI  
Date Received10/14/2008
Decision Date 12/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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