FDA 510(k) Application Details - K070464

Device Classification Name System, Image Processing, Radiological

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510(K) Number K070464
Device Name System, Image Processing, Radiological
Applicant CYBERMED, INC.
#504 SJ TECHNOVILLE,
GASAN-DONG 60-19, GEUMCHEON-GU
SEOUL 153-710 KR
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Contact SONG N CHOI
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 02/16/2007
Decision Date 03/16/2007
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 Y
Expedited Review



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