FDA 510(k) Application Details - K143554

Device Classification Name

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510(K) Number K143554
Device Name Venus Legacy CX
Applicant Venus Concept Ltd.
4556 N.Hiatus Road
Sunrise, FL 33351 US
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Contact Orit Ron Edoute
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Regulation Number

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Classification Product Code PBX
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Date Received 12/15/2014
Decision Date 08/04/2015
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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