FDA 510(k) Application Details - K102557

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K102557
Device Name Lenses, Soft Contact, Daily Wear
Applicant ALDEN OPTICAL LABS., INC.
13295 BROADWAY
ALDEN, NY 14004 US
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Contact CHARLES H CREIGHTON
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 09/07/2010
Decision Date 04/26/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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