FDA 510(k) Application Details - DEN090008

Device Classification Name

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510(K) Number DEN090008
Device Name ERCHONIA ML SCANNER (MLS)
Applicant ERCHONIA MEDICAL
5401 S. COTTONWOOD CT.
GREENWOOD VILLAGE, CO 80121 US
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Contact Kevin Walls
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Regulation Number

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Classification Product Code OLI
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Date Received 01/05/2009
Decision Date 08/24/2010
Decision DENG -
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Post-NSE
Reviewed By Third Party N
Expedited Review



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