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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K230668
Device Name Disposable High-pressure Extension Lines
Applicant
Precision Medical Plastics , Ltd.
2b1401, Smart Park Ii, # 76, Baohe Ave.
Baolong Community, Baolong St., Longgang District
Shenzhen,  CN 518100
Applicant Contact Li Xiaotong
Correspondent
Guangzhou Osmunda Medical Device Technology, Inc.
14f, Bldg. C, Phase Iv Standard Industrial Park
Guangzhou International Bio-Island
Guangzhou,  CN 510320
Correspondent Contact Olivia Meng
Regulation Number870.1650
Classification Product Code
DXT  
Date Received03/10/2023
Decision Date 06/14/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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