FDA 510(k) Application Details - K070683

Device Classification Name System, Image Processing, Radiological

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510(K) Number K070683
Device Name System, Image Processing, Radiological
Applicant SEGAMI CORPORATION
8325 GUILFORD RD., SUITE B
COLUMBIA, MD 21046 US
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Contact PHILIPPE BRIANDET
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 03/12/2007
Decision Date 04/12/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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