FDA 510(k) Application Details - K152724

Device Classification Name Lens, Contact (Other Material) - Daily

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510(K) Number K152724
Device Name Lens, Contact (Other Material) - Daily
Applicant ADVANCED VISION TECHNOLOGIES
969 SOUTH KIPLING PARKWAY
LAKEWOOD, CO 80226 US
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Contact KEITH PARKER
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Regulation Number 886.5916

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Classification Product Code HQD
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Date Received 09/22/2015
Decision Date 04/27/2016
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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