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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K240774
Device Name Pen Injector
Applicant
Wuxi NEST Biotechnology Co., Ltd.
No. 530, Xida Road, Meicun Industrial Park, Xinwu District
Wuxi,  CN 214112
Applicant Contact Cheng Zhiwei
Correspondent
ICAS Group
No.155 Pingbei Road, Minhang District
Shanghai,  CN 201109
Correspondent Contact Ryan Li
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/21/2024
Decision Date 06/18/2024
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
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