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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 K152496
Device Name CPX 4 Breast Tissue Expander
Applicant
Mentor Worldwide, LLC
201 Mentor Dr.
Santa Barbara,  CA  93111
Applicant Contact Manchi Cheung
Correspondent
Mentor Worldwide, LLC
201 Mentor Dr.
Santa Barbara,  CA  93111
Correspondent Contact Manchi Cheung
Classification Product Code
LCJ  
Date Received09/01/2015
Decision Date 02/19/2016
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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