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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Tracheal, Expandable
510(k) Number K141584
Device Name ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
Applicant
Boston Scientific Corporation
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Applicant Contact THOMAS HIRTE
Correspondent
Boston Scientific Corporation
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Correspondent Contact THOMAS HIRTE
Regulation Number878.3720
Classification Product Code
JCT  
Date Received06/13/2014
Decision Date 10/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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