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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 K980163
Device Name WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
5905 NATHAN LN.
MINNEAPOLIS,  MN  55442
Applicant Contact RONALD W BENNETT
Correspondent
BOSTON SCIENTIFIC SCIMED, INC.
5905 NATHAN LN.
MINNEAPOLIS,  MN  55442
Correspondent Contact RONALD W BENNETT
Regulation Number878.3720
Classification Product Code
JCT  
Date Received01/16/1998
Decision Date 03/13/1998
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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