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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 K201356
Device Name Plastic LOR Syringe
Applicant
Jiangsu Caina Medical Co.,Ltd
# 23, Huanxi Rd. Zhutang Town
Jiangyin,  CN 214415
Applicant Contact Jianwei Pan
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received05/21/2020
Decision Date 02/12/2021
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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