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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K132946
Device Name SOFTECH PLUS ETC02 CANNULA
Applicant
Teleflex Medical, Inc.
2917 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Applicant Contact Angela Bouse
Correspondent
Teleflex Medical, Inc.
2917 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Correspondent Contact Angela Bouse
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Code
CAT  
Date Received09/19/2013
Decision Date 06/04/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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