FDA 510(k) Application Details - K080816

Device Classification Name Foot Examination Tool For Inflammatory Changes

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510(K) Number K080816
Device Name Foot Examination Tool For Inflammatory Changes
Applicant VISUAL FOOTCARE TECHNOLOGIES, LLC
P.O. BOX 760
SOUTH SALEM, NY 10590 US
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Contact ANDREW SINGER
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Regulation Number 890.5050

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Classification Product Code OIZ
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Date Received 03/24/2008
Decision Date 06/24/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K080816


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