HORIZONS PAPILLOTOME


the company

Device Classification Name

unit, electrosurgical, endoscopic (with or without accessories)

510(k) Number K002236
Device Name HORIZONS PAPILLOTOME
Original Applicant
HORIZONS INTL. CORP.
200 politecnica st.
villas univ. po box 250435
aguadilla, 
PR 
00604

Original Contact rafic saleh
Regulation Number 876.4300
Classification Product Code
KNS  
Date Received 07/24/2000
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