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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 K011667
Device Name HORIZONS INTERNATIONAL POLYPECTOMY SNARES
Applicant
Horizons Intl. Corp.
P.O. Box 7273
Ponce,  PR  00732
Applicant Contact RAFIC SALEH
Correspondent
Horizons Intl. Corp.
P.O. Box 7273
Ponce,  PR  00732
Correspondent Contact RAFIC SALEH
Regulation Number876.4300
Classification Product Code
FDI  
Date Received05/30/2001
Decision Date 08/16/2001
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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