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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 K021901
Device Name WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Applicant
Boston Scientific Scimed, Inc.
One Scimed Place
Maple Grove,  MN  55311
Applicant Contact SHERRY L SPARROW
Correspondent
Boston Scientific Scimed, Inc.
One Scimed Place
Maple Grove,  MN  55311
Correspondent Contact SHERRY L SPARROW
Regulation Number878.3720
Classification Product Code
JCT  
Date Received06/10/2002
Decision Date 07/09/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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