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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Tracheostomy And Tube Cuff
510(k) Number K081440
Device Name BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES
Applicant
SMITHS MEDICAL ASD, INC.
6250 SHIER RINGS RD.
DUBLIN,  OH  43016
Applicant Contact BARBARA LAW
Correspondent
SMITHS MEDICAL ASD, INC.
6250 SHIER RINGS RD.
DUBLIN,  OH  43016
Correspondent Contact BARBARA LAW
Regulation Number868.5800
Classification Product Code
JOH  
Date Received05/22/2008
Decision Date 09/12/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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