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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 K183316
Device Name Dr J Spinal and Epidural Needles
Dr. Japan Co., Ltd.
1-1 Kagurazaka, Shinjuku-ku
Tokyo,  JP 162-0825
Applicant Contact Mitsuko Uchida
Smith Associates
1468 Harwell Ave
Crofton,  MD  21114
Correspondent Contact Yolanda Smith
Regulation Number868.5150
Classification Product Code
Date Received11/30/2018
Decision Date 08/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No