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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 K092538
Device Name REFINE SUPPORT SYSTEM, MODEL 100.0100
Applicant
ALURE MEDICAL INC.
3637 WESTWIND BLVD., SUITE B
SANTA ROSA,  CA  95403
Applicant Contact JOSEPH TAMAYO
Correspondent
ALURE MEDICAL INC.
3637 WESTWIND BLVD., SUITE B
SANTA ROSA,  CA  95403
Correspondent Contact JOSEPH TAMAYO
Regulation Number878.3300
Classification Product Code
FTL  
Date Received08/19/2009
Decision Date 03/05/2010
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
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