NIR BILIARY STENT


information about

Device Classification Name

catheter, biliary, diagnostic

510(k) Number K002130
Device Name NIR BILIARY STENT
Original Applicant
MEDINOL LTD.
kiryat atidim, building 7
entrance a, 5th fl., pob 58165
tel-aviv, 

IL

61581

Original Contact nasr salman
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 07/14/2000
Decision Date 10/30/2000
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Special
Reviewed by Third Party No

Combination Product

No