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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 K992510
Device Name WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
Applicant
BOSTON SCIENTIFIC CORP.
5905 NATHAN LN.
PLYMOUTH,  MN  55442
Applicant Contact RON BENNETT
Correspondent
BOSTON SCIENTIFIC CORP.
5905 NATHAN LN.
PLYMOUTH,  MN  55442
Correspondent Contact RON BENNETT
Regulation Number878.3720
Classification Product Code
JCT  
Date Received07/27/1999
Decision Date 11/18/1999
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
Recalls CDRH Recalls
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