FDA 510(k) Application Details - K130813

Device Classification Name Expander, Skin, Inflatable

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510(K) Number K130813
Device Name Expander, Skin, Inflatable
Applicant MENTOR CORP.
201 MENTOR DR.
SANTA BARBARA, CA 93111 US
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Contact MARTIN SPRUNCK
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Regulation Number 000.0000

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Classification Product Code LCJ
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Date Received 03/25/2013
Decision Date 04/11/2013
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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