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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Non-Powered
510(k) Number K220920
Device Name Matreneu Percutaneous Balloon Compression Kit
Applicant
Shenzhen Shineyard Medical Device Co. Ltd.
3F, Changfeng Industrial Block No.3 Liuxian Road,
Xin’an Bao’an District,
Shenzhen,  CN 518000
Applicant Contact Yan Ping
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713A, 17th Floor, Block A, Zhongguan Times Square,
Nanshan District
Shenzhen,  CN 518100
Correspondent Contact Joyce Yang
Regulation Number882.4535
Classification Product Code
HAO  
Date Received03/30/2022
Decision Date 09/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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