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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 K170720
Device Name Portex Blue Line Ultra Paediatric Tracheosomy Tube
Applicant
Smiths Medical ASD, Inc.
6000 Nathan Lane North
Minneapolis,  MN  55442
Applicant Contact James Taufen
Correspondent
Smiths Medical ASD, Inc.
6000 Nathan Lane North
Minneapolis,  MN  55442
Correspondent Contact James Taufen
Regulation Number868.5800
Classification Product Code
JOH  
Date Received03/09/2017
Decision Date 12/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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