FDA 510(k) Application Details - K112302

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K112302
Device Name Lenses, Soft Contact, Daily Wear
Applicant COOPER VISION, INC.
6150 STONERIDGE MALL ROAD
PLEASANTON, CA 94588 US
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Contact LISA HAHN
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 08/11/2011
Decision Date 12/21/2011
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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