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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K260301
Device Name Vial Adapter
Applicant
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
Rm. 104, 201, 301, 302, Bldg. 12, Block 1, # 619
Wangmei Rd., Linping Subdistrict, Linping District
Hangzhou,  CN 310000
Applicant Contact Meijun Chen
Correspondent
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
Rm. 104, 201, 301, 302, Bldg. 12, Block 1, # 619
Wangmei Rd., Linping Subdistrict, Linping District
Hangzhou,  CN 310000
Correspondent Contact Meijun Chen
Regulation Number880.5440
Classification Product Code
LHI  
Date Received01/30/2026
Decision Date 06/05/2026
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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