FDA 510(k) Application Details - K041608

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K041608
Device Name Lenses, Soft Contact, Daily Wear
Applicant UNILENS CORP., USA
10431 72ND ST. NORTH
LARGO, FL 33777 US
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Contact JOSEPHA BRUNO
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 06/15/2004
Decision Date 07/07/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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