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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 K050832
Device Name FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT
Applicant
Bard Peripheral Vascular, Inc.
P.O. Box 1740
Tempe,  AZ  85280
Applicant Contact DENNIS SALZMANN
Correspondent
Bard Peripheral Vascular, Inc.
P.O. Box 1740
Tempe,  AZ  85280
Correspondent Contact DENNIS SALZMANN
Regulation Number878.3720
Classification Product Code
JCT  
Date Received04/01/2005
Decision Date 07/07/2005
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
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