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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name display, diagnostic radiology
510(k) Number K151972
Device Name JUSHA-C43 LCD Monitor
Applicant
Nanjing Jusha Display Technology Co., Ltd
301, Hnazhongmen Street, 8F, No. 1
Nanjing International Service Outsourcing
Mansion, Nanjing,  CN 210036
Applicant Contact Ma Jing
Correspondent
Nanjing Jusha Display Technology Co., Ltd
301, Hnazhongmen Street, 8F, No. 1
Nanjing International Service Outsourcing
Mansion, Nanjing,  CN 210036
Correspondent Contact Ma Jing
Regulation Number892.2050
Classification Product Code
PGY  
Date Received07/16/2015
Decision Date 09/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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