FDA 510(k) Application Details - K132684

Device Classification Name System, Image Processing, Radiological

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510(K) Number K132684
Device Name System, Image Processing, Radiological
Applicant MEDECOM SARL
2 RUE QUENOT
JARNAC 16 200 FR
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Contact CYNTHIA COTTEREAU
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 08/28/2013
Decision Date 05/23/2014
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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