FDA 510(k) Application Details - K100874

Device Classification Name Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

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510(K) Number K100874
Device Name Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Applicant MEDICIS TECHNOLOGIES CORPORATION
COLUMBIA SQUARE
555 13TH STREET NW
WASHINGTON, DC 20004 US
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Contact JONATHAN KAHAN
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Regulation Number 878.4590

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Classification Product Code OHV
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Date Received 03/30/2010
Decision Date 08/19/2011
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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