FDA 510(k) Application Details - K121695

Device Classification Name

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510(K) Number K121695
Device Name ERCHONIA ZERONA
Applicant ERCHONIA CORPORATION
33 Golden Eagle Lane
Littleton, CO 80127 US
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Contact Kevin Walls
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Regulation Number

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Classification Product Code OLI
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Date Received 06/07/2012
Decision Date 08/23/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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