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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 K242963
Device Name MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs
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
LCJ  
Date Received09/25/2024
Decision Date 04/24/2025
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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