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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, conduction, anesthetic (w/wo introducer)
510(k) Number K193131
Device Name BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle
Applicant
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Applicant Contact Murtaza Rana
Correspondent
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Correspondent Contact Murtaza Rana
Regulation Number868.5150
Classification Product Code
BSP  
Date Received11/12/2019
Decision Date 09/29/2020
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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