FDA 510(k) Application Details - K180663

Device Classification Name System, X-Ray, Stationary

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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
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Regulation Number 892.1680

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Classification Product Code KPR
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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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