FDA 510(k) Application Details - K132729

Device Classification Name Apparatus, Gas-Scavenging

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510(K) Number K132729
Device Name Apparatus, Gas-Scavenging
Applicant Teleflex Medical, Inc.
2917 WECK DR.
RESEARCH TRIANGLE PARK, NC 27709 US
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Contact Angela Bouse
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Regulation Number 868.5430

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Classification Product Code CBN
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Date Received 09/03/2013
Decision Date 01/09/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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