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FDA 510(k) Application Details - DEN090008
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN090008
Device Name
ERCHONIA ML SCANNER (MLS)
Applicant
ERCHONIA MEDICAL
5401 S. COTTONWOOD CT.
GREENWOOD VILLAGE, CO 80121 US
Other 510(k) Applications for this Company
Contact
Kevin Walls
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OLI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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