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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Conduction, Anesthetic
510(k) Number K230603
Device Name Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)
Applicant
Teleflex Medical
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Applicant Contact Kristen Bisanz
Correspondent
Teleflex Medical
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Correspondent Contact Kristen Bisanz
Regulation Number868.5120
Classification Product Code
BSO  
Subsequent Product Code
CAZ  
Date Received03/03/2023
Decision Date 08/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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