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FDA 510(k) Application Details - K042555
Device Classification Name
Marker, Skin
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510(K) Number
K042555
Device Name
Marker, Skin
Applicant
SURGICHIP, INC.
4398 HICKORY DRIVE
PALM GARDENS, FL 33418 US
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BRUCE WAXMAN
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Regulation Number
878.4660
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Classification Product Code
FZZ
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Date Received
09/20/2004
Decision Date
11/09/2004
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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