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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mammary Sizer
510(k) Number K062421
Device Name MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER
Applicant
MENTOR CORPORATION
201 MENTOR DRIVE
SANTA BARBARA,  CA  93111
Applicant Contact NICOLA SELLEY
Correspondent
MENTOR CORPORATION
201 MENTOR DRIVE
SANTA BARBARA,  CA  93111
Correspondent Contact NICOLA SELLEY
Classification Product Code
MRD  
Date Received08/18/2006
Decision Date 10/10/2006
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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