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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mammary Sizer
510(k) Number K131853
Device Name MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER
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
MRD  
Date Received06/21/2013
Decision Date 07/17/2013
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
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