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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 Road, 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
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