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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 K150777
Device Name Artoura Breast Tissue Expander
Applicant
Mentor Worldwide, LLC
201 Mentor Dr.
Santa Barbara,  CA  93111
Applicant Contact Manchi Cheung
Correspondent
Mentor Worldwide, LLC
201 Mentor Dr.
Santa Barbara,  CA  93111
Correspondent Contact Manchi Cheung
Classification Product Code
LCJ  
Date Received03/25/2015
Decision Date 04/24/2015
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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