FDA 510(k) Application Details - K110040

Device Classification Name System, Image Processing, Radiological

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510(K) Number K110040
Device Name System, Image Processing, Radiological
Applicant MODERN MODULE INC
425 CHEONGCHUN-DONG,
BUPYUNG-KU
LNCHEON KR
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Contact SAMUEL KOH
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 01/06/2011
Decision Date 01/26/2011
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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