HORIZONS ERCP CANNULA


codes

Device Classification Name

catheter, biliary, diagnostic

510(k) Number K002235
Device Name HORIZONS ERCP CANNULA
Original Applicant
HORIZONS INTL. CORP.
200 politecnica st.
villas univ. po box 250435
aguadilla, 
PR 
00604

Original Contact rafic saleh
Regulation Number 876.5010
Classification Product Code
FGE  
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