FDA 510(k) Application Details - K141713

Device Classification Name System, Suction, Lipoplasty

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510(K) Number K141713
Device Name System, Suction, Lipoplasty
Applicant INGENERON, INC.
8205 El Rio St
Houston, TX 77054 US
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Contact ANITA KADALA
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Regulation Number 878.5040

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Classification Product Code MUU
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Date Received 06/25/2014
Decision Date 10/28/2014
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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