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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 K031041
Device Name FLUENCY TRACHEOBRONCHIAL STENT GRAFT
Applicant
Bard Peripheral Vascular
1625 W. 3rd St.
Tempe,  AZ  85281
Applicant Contact AYMEE R BERRY
Correspondent
Bard Peripheral Vascular
1625 W. 3rd St.
Tempe,  AZ  85281
Correspondent Contact AYMEE R BERRY
Regulation Number878.3720
Classification Product Code
JCT  
Date Received04/01/2003
Decision Date 06/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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