FDA 510(k) Application Details - K190386

Device Classification Name System, Suction, Lipoplasty

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510(K) Number K190386
Device Name System, Suction, Lipoplasty
Applicant Stemics S.A.S
2 Rue Professeur Paul Milleret
Besancon 25000 FR
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Contact Stephane Giraud
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Regulation Number 878.5040

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Classification Product Code MUU
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Date Received 02/19/2019
Decision Date 10/10/2019
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

FDA Source Information for K190386


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