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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 K210983
Device Name BD Epilor Syringe
Applicant
Becton Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Applicant Contact Huwien Yang
Correspondent
Becton Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Correspondent Contact Huwien Yang
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received04/01/2021
Decision Date 05/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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