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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K002236
Device Name HORIZONS PAPILLOTOME
Applicant
HORIZONS INTL. CORP.
200 POLITECNICA ST.
VILLAS UNIV. PO BOX 250435
AGUADILLA,  PR  00604
Applicant Contact RAFIC SALEH
Correspondent
HORIZONS INTL. CORP.
200 POLITECNICA ST.
VILLAS UNIV. PO BOX 250435
AGUADILLA,  PR  00604
Correspondent Contact RAFIC SALEH
Regulation Number876.4300
Classification Product Code
KNS  
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
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