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FDA 510(k) Application Details - K122528
Device Classification Name
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
More FDA Info for this Device
510(K) Number
K122528
Device Name
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Applicant
ULTHERA, INC.
1840 S Stapley Dr Suite 200
Mesa, AZ 85204 US
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Contact
SUZON LOMMEL
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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
08/20/2012
Decision Date
08/28/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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