FDA 510(k) Application Details - K203800

Device Classification Name System, Suction, Lipoplasty

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510(K) Number K203800
Device Name System, Suction, Lipoplasty
Applicant Syntr Health Technologies, Inc.
5270 California Ave., Suite #300
Irvine, CA 92617 US
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Contact Ahmed Zobi
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Regulation Number 878.5040

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Classification Product Code MUU
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Date Received 12/28/2020
Decision Date 07/02/2021
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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