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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 K093067
Device Name LIPOSE DISPOSABLE CANNULA
Applicant
Lipose Corp.
1205 De La Vina St.
Santa Barbara,  CA  93101
Applicant Contact CHRISTINE EMANUEL
Correspondent
Lipose Corp.
1205 De La Vina St.
Santa Barbara,  CA  93101
Correspondent Contact CHRISTINE EMANUEL
Regulation Number878.5040
Classification Product Code
QPB  
Date Received09/30/2009
Decision Date 12/29/2009
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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