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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, gas-scavenging
510(k) Number K132729
Device Name ISO-GARD MASK
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 Number868.5430
Classification Product Code
CBN  
Date Received09/03/2013
Decision Date 01/09/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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