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FDA 510(k) Application Details - DEN080006
Device Classification Name
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
More FDA Info for this Device
510(K) Number
DEN080006
Device Name
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Applicant
ULTHERA, INC.
33 SOUTH SYCAMORE STREET
MESA, AZ 85202 US
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Contact
RANDALL E MILLER
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Regulation Number
878.4590
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Classification Product Code
OHV
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More FDA Info for this Product Code
Date Received
04/11/2008
Decision Date
09/11/2009
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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