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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K193022
Device Name Retractable Safety Insulin Syringe
Applicant
Jiangsu Caina Medical Co.,Ltd
#23, Huanxi Rd., Zhutang Town
Jiangyin,  CN 214425
Applicant Contact Xinyan Ruan
Correspondent
Jiangsu Caina Medical Co.,Ltd
# 23, Huanxi Rd. Zhutang Town
Jiangyin,  CN 214415
Correspondent Contact Xinyan Ruan
Regulation Number880.5860
Classification Product Code
MEG  
Date Received10/30/2019
Decision Date 07/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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