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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 K141684
Device Name JUSHA-C33C LCD MONITOR
Applicant
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD
8A, BLOCK 1 NANJING INTERNATIONAL SERVICE OUTSOURCING
MANSION, NO. 301
HAUZHONGMEN STREET, NANJING,  CN 210036
Applicant Contact LI LE
Correspondent
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD
8A, BLOCK 1 NANJING INTERNATIONAL SERVICE OUTSOURCING
MANSION, NO. 301
HAUZHONGMEN STREET, NANJING,  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
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