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510(k) K062421

MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER by Mentor Corporation — Product Code MRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2006
Date Received
August 18, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mammary Sizer
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Mentor Corporation

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  • K052440 — MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER (October 11, 2005)
  • K050148 — MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT (March 9, 2005)

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  • K151055 — Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE (May 20, 2015)
  • K131853 — MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER (July 17, 2013)
  • K010709 — MENTOR STERILE SALINE MAMMARY VOLUME SIZERS (April 23, 2001)
  • K984106 — MAMMARY SIZER, MAMMARY PROTHESIS SIZER (February 12, 1999)
  • K982258 — MAMMARY SIZER (September 8, 1998)