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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 K160355
Device Name CX20N(CX20PUX)
Applicant
WIDE Corporation
12 Wongomae-Ro, Giheung-Gu
Yongin-Si,  KR 17086
Applicant Contact YeoJin Yun
Correspondent
WIDE Corporation
12 Wongomae-Ro, Giheung-Gu
Yongin-Si,  KR 17086
Correspondent Contact YeoJin Yun
Regulation Number892.2050
Classification Product Code
PGY  
Date Received02/08/2016
Decision Date 04/07/2016
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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