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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 K130813
Device Name MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS
Applicant
Mentor Corp.
201 Mentor Dr.
Santa Barbara,  CA  93111
Applicant Contact MARTIN SPRUNCK
Correspondent
Mentor Corp.
201 Mentor Dr.
Santa Barbara,  CA  93111
Correspondent Contact MARTIN SPRUNCK
Classification Product Code
LCJ  
Date Received03/25/2013
Decision Date 04/11/2013
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
Recalls CDRH Recalls
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