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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 K243836
Device Name Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander
Applicant
Mentor Worldwide, LLC
31 Technology Dr.
Irvine,  CA  92618
Applicant Contact Catherine Carvalho
Correspondent
Mentor Worldwide, LLC
31 Technology Dr.
Irvine,  CA  92618
Correspondent Contact Catherine Carvalho
Classification Product Code
LCJ  
Date Received12/13/2024
Decision Date 01/12/2025
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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