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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Esophageal
510(k) Number K080838
Device Name ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
Applicant
Alveolus, Inc.
9013 Perimeter Woods Dr.
Suite A
Charlotte,  NC  28216
Applicant Contact TONY D ALEXANDER
Correspondent
Alveolus, Inc.
9013 Perimeter Woods Dr.
Suite A
Charlotte,  NC  28216
Correspondent Contact TONY D ALEXANDER
Regulation Number878.3610
Classification Product Code
ESW  
Date Received03/25/2008
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
Predetermined Change
Control Plan Authorized		 No
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