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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Polymeric
510(k) Number K083102
Device Name REFINE LIFT SYSTEM
Applicant
Alure Medical, Inc.
2445 Impala Dr.
Carlsbad,  CA  92010
Applicant Contact JASPER BENKE
Correspondent
Alure Medical, Inc.
2445 Impala Dr.
Carlsbad,  CA  92010
Correspondent Contact JASPER BENKE
Regulation Number878.3300
Classification Product Code
FTL  
Date Received10/20/2008
Decision Date 05/11/2009
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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