FDA 510(k) Application Details - K111345

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K111345
Device Name Lenses, Soft Contact, Daily Wear
Applicant THE SEE CLEAR COMPANY, INC
16576 W. 53rd way
Golden, CO 80403 US
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Contact KEVIN RANDALL
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 05/13/2011
Decision Date 11/02/2011
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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