FDA 510(k) Application Details - K222341

Device Classification Name Anesthesia Conduction Kit

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510(K) Number K222341
Device Name Anesthesia Conduction Kit
Applicant Arrow International, LLC
3015 Carrington Mill Blvd
Morrisville, NC 27560 US
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Contact Ann Metz
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Regulation Number 868.5140

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Classification Product Code CAZ
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Date Received 08/03/2022
Decision Date 02/13/2023
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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