MODIFICATION TO ZILVER 635 BILIARY STENT


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K080037
Device Name MODIFICATION TO ZILVER 635 BILIARY STENT
Applicant
COOK, INC.
750 daniels way
p.o. box 489
bloomington, 
IN 
47402

Applicant Contact stephanie roberts
Correspondent
COOK, INC.
750 daniels way
p.o. box 489
bloomington, 
IN 
47402

Correspodent Contact stephanie roberts
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 01/07/2008
Decision Date 08/01/2008
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No