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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Suction, Lipoplasty For Removal
510(k) Number K063235
Device Name CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT
Applicant
Cytori Therapeutics, Inc.
3020 Callan Rd.
San Diego,  CA  92121 -1109
Applicant Contact KENNETH K KLEINHENZ
Correspondent
Cytori Therapeutics, Inc.
3020 Callan Rd.
San Diego,  CA  92121 -1109
Correspondent Contact KENNETH K KLEINHENZ
Regulation Number878.5040
Classification Product Code
QPB  
Date Received10/25/2006
Decision Date 01/24/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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