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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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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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