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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 K122235
Device Name RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
Applicant
Teleflex Medical, Inc.
2917 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Applicant Contact LORI PFOHL
Correspondent
Teleflex Medical, Inc.
2917 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Correspondent Contact LORI PFOHL
Regulation Number868.5800
Classification Product Code
JOH  
Date Received07/26/2012
Decision Date 09/06/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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