FDA 510(k) Application Details - K040171

Device Classification Name

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510(K) Number K040171
Device Name MICRODERM, MODEL/VERSION 3.5
Applicant VISIOMED AG
20310 SW 48TH STREET
FT. LAUDERDALE, FL 33332 US
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Contact JOHN GREENBAUM
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Regulation Number

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Classification Product Code PSN
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Date Received 01/26/2004
Decision Date 06/08/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
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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