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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 K171518
Device Name Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles
Zhejiang kindly Medical Devices Co., Ltd
No.758, 5th Binhai Road, Binhai Industrial Park
Longwan District
Wenzhou,  CN 325025
Applicant Contact Zenghua Zhang
Mid-Link Consulting Co., Ltd
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number868.5150
Classification Product Code
Date Received05/24/2017
Decision Date 01/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No