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FDA 510(k) Application Details - K160354
Device Classification Name
More FDA Info for this Device
510(K) Number
K160354
Device Name
MX50T(MX50TQS)
Applicant
WIDE CORPORATION
12 WONGOMAE-RO, GIHEUNG-GU
YONGIN-SI 17086 KR
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Contact
YeoJin Yun
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PGY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/08/2016
Decision Date
05/02/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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