FDA 510(k) Application Details - K161636

Device Classification Name System, Suction, Lipoplasty

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510(K) Number K161636
Device Name System, Suction, Lipoplasty
Applicant Lipogems International SpA
viale Bianca Maria 24
Milano 20129 IT
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Contact CARLO RUSSO
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Regulation Number 878.5040

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Classification Product Code MUU
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Date Received 06/14/2016
Decision Date 11/04/2016
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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