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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 K141679
Device Name JUSHA-C61 LCD MONITOR
Applicant
Nanjing Jusha Display Technology Co., Ltd.
8a, Block 1, Nanjing Intl Service Outsourcing Mansion
# 301, Hanzhongmen St.
Nanjing, Jiangsu,  CN 210036
Applicant Contact LI LE
Correspondent
Nanjing Jusha Display Technology Co., Ltd.
8a, Block 1, Nanjing Intl Service Outsourcing Mansion
# 301, Hanzhongmen St.
Nanjing, Jiangsu,  CN 210036
Correspondent Contact LI LE
Regulation Number892.2050
Classification Product Code
PGY  
Date Received06/23/2014
Decision Date 08/01/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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