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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 K934116
Device Name WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION
Applicant
Boston Scientific Scimed, Inc.
5905 Nathan Ln.
Plymouth,  MN  55442
Applicant Contact AMY PETERSON
Correspondent
Boston Scientific Scimed, Inc.
5905 Nathan Ln.
Plymouth,  MN  55442
Correspondent Contact AMY PETERSON
Regulation Number878.3720
Classification Product Code
JCT  
Date Received08/25/1993
Decision Date 06/02/1994
Decision SE SUBJECT TO TRACKING REG (ST)
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
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