ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K991793
Device Name ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM
Applicant
ANGIODYNAMICS, INC.
603 queensbury ave.
queensbury, 
NY 
12804

Applicant Contact teri juckett
Correspondent
ANGIODYNAMICS, INC.
603 queensbury ave.
queensbury, 
NY 
12804

Correspodent Contact teri juckett
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 05/26/1999
Decision Date 06/25/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No