FDA 510(k) Application Details - K151055

Device Classification Name Sizer, Mammary, Breast Implant Volume

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510(K) Number K151055
Device Name Sizer, Mammary, Breast Implant Volume
Applicant MENTOR WORLDWIDE LLC
201 MENTOR DRIVE
SANTA BARBARA, CA 93111 US
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Contact Sarah McManus
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Regulation Number 000.0000

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Classification Product Code MRD
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Date Received 04/20/2015
Decision Date 05/20/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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