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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 K152842
FOIA Releasable 510(k) K152842
Device Name WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
Applicant
Boston Scientific Corporation
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact CARAH KUCHARSKI
Correspondent
Boston Scientific Corporation
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact CARAH KUCHARSKI
Regulation Number878.3720
Classification Product Code
JCT  
Date Received09/29/2015
Decision Date 05/19/2016
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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