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FDA 510(k) Application Details - K172180
Device Classification Name
More FDA Info for this Device
510(K) Number
K172180
Device Name
OSCAR 15
Applicant
Genoray Co.,Ltd
512, 560, Dunchon-daero, Jungwon-gu
Seongnam-si 13230 KR
Other 510(k) Applications for this Company
Contact
Ji-Yeon Choi
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/19/2017
Decision Date
02/09/2018
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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