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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 K151055
Device Name Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE
Applicant
Mentor Worldwide, LLC
201 Mentor Dr.
Santa Barbara,  CA  93111
Applicant Contact Sarah McManus
Correspondent
Mentor Worldwide, LLC
201 Mentor Dr.
Santa Barbara,  CA  93111
Correspondent Contact Sarah McManus
Classification Product Code
MRD  
Date Received04/20/2015
Decision Date 05/20/2015
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
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