FDA 510(k) Application Details - K100095

Device Classification Name Chart, Visual Acuity

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510(K) Number K100095
Device Name Chart, Visual Acuity
Applicant VIMETRICS,LLC.
311 E. BALTIMORE AVE
SUITE 100
MEDIA, PA 19063 US
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Contact STEPHEN H H SINCLAIR,MD
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Regulation Number 886.1150

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Classification Product Code HOX
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Date Received 01/13/2010
Decision Date 05/10/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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