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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Contact 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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