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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 K192657
Device Name Sterile High-pressure Angiographic Syringes for Single-use
Applicant
Shenzhen Boon Medical Supply Co., Ltd.
No 6 Shenkeng Rd., Shenkeng Industrial Zon Liuyue Community
Henggang
Shenzhen,  CN 518173
Applicant Contact Mingan Mu
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.1650
Classification Product Code
DXT  
Date Received09/25/2019
Decision Date 08/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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