ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K072720
Device Name ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM
Applicant
ALVEOLUS, INC.
9013 perimeter woods drive
suite a
charlotte, 
NC 
28216

Applicant Contact tony d alexander
Correspondent
ALVEOLUS, INC.
9013 perimeter woods drive
suite a
charlotte, 
NC 
28216

Correspodent Contact tony d alexander
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 09/25/2007
Decision Date 04/11/2008
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

Recalls CDRH Recalls