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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 K133173
Device Name RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET
Applicant
Teleflexmedical, Inc.
2917 Weck Dr.
Durham,  NC  27709
Applicant Contact LORI PFOHL
Correspondent
Teleflexmedical, Inc.
2917 Weck Dr.
Durham,  NC  27709
Correspondent Contact LORI PFOHL
Regulation Number868.5800
Classification Product Code
JOH  
Date Received10/17/2013
Decision Date 05/23/2014
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
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