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FDA 510(k) Application Details - K080300
Device Classification Name
Massager, Vacuum, Light Induced Heating
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510(K) Number
K080300
Device Name
Massager, Vacuum, Light Induced Heating
Applicant
CUTERA, INC.
3240 BAYSHORE BLVD
BRISBANE, CA 94005 US
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Contact
KATHY MAYNOR
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Regulation Number
878.4810
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Classification Product Code
NUV
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More FDA Info for this Product Code
Date Received
02/05/2008
Decision Date
04/08/2008
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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