FDA 510(k) Application Details - K082799

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

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510(K) Number K082799
Device Name Lens, Contact (Other Material) - Daily
Applicant PARAGON VISION SCIENCES
947 EAST IMPALA AVE.
MESA, AZ 85204 US
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Contact WILLIAM MEYERS
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Regulation Number 886.5916

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Classification Product Code HQD
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Date Received 09/23/2008
Decision Date 01/27/2009
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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