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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 K210229
Device Name Sterile Auto-Disable Syringes with/without Needle for Single Use
Applicant
Zhejiang Kangkang Medical-Devices CO., Ltd.
Longwang Industrial District, Chumen Town
Yuhuan,  CN 317605
Applicant Contact Chun Guo
Correspondent
Zhejiang Kangkang Medical-Devices CO., Ltd.
Longwang Industrial District, Chumen Town
Yuhuan,  CN 317605
Correspondent Contact Chun Guo
Regulation Number880.5860
Classification Product Code
MEG  
Date Received01/28/2021
Decision Date 02/15/2022
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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