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FDA 510(k) Application Details - K180663
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
510(K) Number
K180663
Device Name
System, X-Ray, Stationary
Applicant
LIVERMORETECH Inc.
801 North Jupiter Rd, Suite 200
Plano, TX 75074 US
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Contact
Jae Hong Kim
Other 510(k) Applications for this Contact
Regulation Number
892.1680
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Classification Product Code
KPR
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More FDA Info for this Product Code
Date Received
03/14/2018
Decision Date
05/18/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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