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FDA 510(k) Application Details - K122389
Device Classification Name
More FDA Info for this Device
510(K) Number
K122389
Device Name
TRUSCULPT
Applicant
CUTERA, INC.
3240 BAYSHORE BLVD
BRISBANE, CA 94005 US
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Contact
Connie Hoy
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Regulation Number
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Classification Product Code
PBX
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Date Received
08/07/2012
Decision Date
11/02/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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