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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 K241552
Device Name MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer
Applicant
Mentor Worldwide, LLC
31 Technology Dr.
Irvine,  CA  92614
Applicant Contact Alicia Botham
Correspondent
Mentor Worldwide, LLC
31 Technology Dr.
Irvine,  CA  92614
Correspondent Contact Alicia Botham
Classification Product Code
MRD  
Date Received05/31/2024
Decision Date 09/06/2024
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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