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FDA 510(k) Application Details - K163115
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
510(K) Number
K163115
Device Name
System, X-Ray, Stationary
Applicant
SAMSUNG ELECTRONICS CO., LTD.
129, SAMSUNG-RO, YEONGTONG-GU
SUWON-SI 16677 KR
Other 510(k) Applications for this Company
Contact
CHULSIN KIM
Other 510(k) Applications for this Contact
Regulation Number
892.1680
More FDA Info for this Regulation Number
Classification Product Code
KPR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/07/2016
Decision Date
12/07/2016
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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