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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 K003100
Device Name WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP 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 Received10/03/2000
Decision Date 12/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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