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FDA 510(k) Application Details - K151219
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
510(K) Number
K151219
Device Name
System, X-Ray, Stationary
Applicant
BEIJING POLYCON MEDICAL ENGINEERING COMPANY
HAI DIAN QU BUILDING 9
FU WAI LIANG JIA DIAN
BEIJING 100142 CN
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Contact
XIANGCHEN LIU
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
05/07/2015
Decision Date
08/04/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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