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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Infusion Line
510(k) Number K233277
Device Name Filter Needle for Single Use
Applicant
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
104, 301, 302, Bldg. 12, Bldg. 1,619 Wangmei
Rd.inping St., Linping District
Hangzhou,  CN 311199
Applicant Contact Chunyu Wang
Correspondent
Shanghai Lingfu Technology Co., Ltd.
4f # 585-2, Wanyuan Rd. Minhang District
Shanghai,  CN 201102
Correspondent Contact Esther Zhang
Regulation Number880.5440
Classification Product Code
FPB  
Date Received09/29/2023
Decision Date 05/10/2024
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
Predetermined Change
Control Plan Authorized		 No
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