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FDA 510(k) Application Details - K132028
Device Classification Name
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
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510(K) Number
K132028
Device Name
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Applicant
ULTHERA, INC.
2150 S. Country Club Drive
Suite 21
Mesa, AZ 85210 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
07/01/2013
Decision Date
12/11/2013
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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