FDA 510(k) Application Details - K143211

Device Classification Name Grid, Amsler

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510(K) Number K143211
Device Name Grid, Amsler
Applicant VITAL ART AND SCIENCE INCORPORATED
2725 N. SPRING DR.
RICHARDSON, TX 75082 US
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Contact Michael Bartlett
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Regulation Number 886.1330

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Classification Product Code HOQ
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Date Received 11/10/2014
Decision Date 03/20/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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