FDA 510(k) Application Details - K062421

Device Classification Name Sizer, Mammary, Breast Implant Volume

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510(K) Number K062421
Device Name Sizer, Mammary, Breast Implant Volume
Applicant MENTOR CORPORATION
201 MENTOR DRIVE
SANTA BARBARA, CA 93111 US
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Contact NICOLA SELLEY
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Regulation Number 000.0000

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Classification Product Code MRD
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Date Received 08/18/2006
Decision Date 10/10/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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