FDA 510(k) Application Details - K070606

Device Classification Name System, Image Processing, Radiological

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510(K) Number K070606
Device Name System, Image Processing, Radiological
Applicant KEOSYS S.A.S.
IMPASSE AUGUSTIN FRESNEL,
Z.A. DU MOULIN NEUF
SAINT-HERBLAIN 44815 FR
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Contact ANTHONY MOTTIER
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 03/05/2007
Decision Date 04/24/2007
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 N
Expedited Review



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