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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
510(k) Number K112626
Device Name LIPSONIX(R) SYSTEM MODEL 2
Applicant
MEDICIS TECHNOLOGIES CORPORATION
11818 NORTH CREEK PARKWAY N.
BOTHELL,  WA  98011
Applicant Contact MICHAEL A HOFFMAN
Correspondent
MEDICIS TECHNOLOGIES CORPORATION
11818 NORTH CREEK PARKWAY N.
BOTHELL,  WA  98011
Correspondent Contact MICHAEL A HOFFMAN
Regulation Number878.4590
Classification Product Code
OHV  
Date Received09/09/2011
Decision Date 10/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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