FDA 510(k) Application Details - K112832

Device Classification Name Case, Contact Lens

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510(K) Number K112832
Device Name Case, Contact Lens
Applicant EYE CARE AND CURE
4646 S OVERLAND DR
TUCSON, AZ 85714 US
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Contact LINDY V DALEN
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Regulation Number 886.5928

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Classification Product Code LRX
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Date Received 09/29/2011
Decision Date 12/05/2011
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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