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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 K212949
Device Name Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use
Applicant
Henan Nursecare Biotechnology Co., Ltd.
Bldg. C1, Xindong Science Park, # 299 Dongzhuo Rd.
Xinxiang,  CN 453700
Applicant Contact Yaping Zhang
Correspondent
Cnmed Consultant
31 Archer St.
Upper Mount Gravatt,  AU 4122
Correspondent Contact Johnson Liu
Regulation Number880.5860
Classification Product Code
MEG  
Subsequent Product Codes
FMF   FMI  
Date Received09/16/2021
Decision Date 02/24/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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