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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 K182335
Device Name CPX 4 Breast Tissue Expander with Smooth Surface
Applicant
Mentor Worldwide, LLC
33 Technology Dr.
Irvin,  CA  92618
Applicant Contact Martin Sprunck
Correspondent
Mentor Worldwide, LLC
33 Technology Dr.
Irvin,  CA  92618
Correspondent Contact Martin Sprunck
Classification Product Code
LCJ  
Date Received08/28/2018
Decision Date 09/25/2018
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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