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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K222341
Device Name Arrow 0.2 Micron Flat Filter, GVS
Applicant
Arrow International, LLC
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Applicant Contact Ann Metz
Correspondent
Arrow International, LLC
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Correspondent Contact Ann Metz
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received08/03/2022
Decision Date 02/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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