FDA 510(k) Application Details - K110452

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K110452
Device Name Lenses, Soft Contact, Daily Wear
Applicant UNILENS CORP., USA
10431 72ND ST. NORTH
LARGO, FL 33777 US
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Contact ALAN J FRAZER
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 02/16/2011
Decision Date 04/20/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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