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FDA 510(k) Application Details - K162512
Device Classification Name
More FDA Info for this Device
510(K) Number
K162512
Device Name
truSculpt
Applicant
CUTERA, INC.
3240 BAYSHORE BLVD.
BRISBANE, CA 94005 US
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Contact
BRADLEY RENTON
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Regulation Number
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Classification Product Code
PBX
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More FDA Info for this Product Code
Date Received
09/08/2016
Decision Date
12/09/2016
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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