FDA 510(k) Application Details - K230603

Device Classification Name Catheter, Conduction, Anesthetic

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510(K) Number K230603
Device Name Catheter, Conduction, Anesthetic
Applicant Teleflex Medical
3015 Carrington Mill Blvd.
Morrisville, NC 27560 US
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Contact Kristen Bisanz
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Regulation Number 868.5120

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Classification Product Code BSO
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Date Received 03/03/2023
Decision Date 08/30/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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