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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 K083641
Device Name BIVONA TRACHEOSTOMY TUBES
Applicant
SMITHS MEDICAL ASD, INC.
5700 WEST 23RD AVE.
GARY,  IN  46406
Applicant Contact DANIEL COATES
Correspondent
SMITHS MEDICAL ASD, INC.
5700 WEST 23RD AVE.
GARY,  IN  46406
Correspondent Contact DANIEL COATES
Regulation Number868.5800
Classification Product Code
JOH  
Date Received12/09/2008
Decision Date 02/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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