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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K253622
Device Name Safety Pen Needle
Applicant
Ningbo Medsun Medical Co., Ltd.
# 298 Huangjipu Rd., Jiangbei,
Ningbo,  CN 315031
Applicant Contact Ping Liu
Correspondent
Ningbo Medsun Medical Co., Ltd.
# 298 Huangjipu Rd., Jiangbei,
Ningbo,  CN 315031
Correspondent Contact Ping Liu
Regulation Number880.5570
Classification Product Code
FMI  
Date Received11/18/2025
Decision Date 03/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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