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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tissue Expander And Accessories
510(k) Number K161176
Device Name ARTOURA Breast Tissue Expanders with Smooth Surface
Applicant
Mentor Worldwide, LLC
33 Technology Dr.
Irvin,  CA  92618
Applicant Contact LAURA C. VELLUCCI
Correspondent
Mentor Worldwide, LLC
33 Technology Dr.
Irvin,  CA  92618
Correspondent Contact LAURA C. VELLUCCI
Classification Product Code
LCJ  
Date Received04/26/2016
Decision Date 05/23/2016
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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