ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM


Device Classification Name

prosthesis, esophageal

510(k) Number K080838
Device Name ALVEOLUS ALIMAXX-E ESOPHAGEAL 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 878.3610
Classification Product Code
ESW  
Date Received 03/25/2008
Decision Date 04/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No