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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 K073266
Device Name WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
Applicant
BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Applicant Contact NEIL KELLY
Correspondent
BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Correspondent Contact NEIL KELLY
Regulation Number878.3610
Classification Product Code
ESW  
Date Received11/20/2007
Decision Date 02/27/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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