FDA 510(k) Application Details - K092852

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K092852
Device Name Lenses, Soft Contact, Daily Wear
Applicant ST. SHINE OPTICAL CO., LTD.
4,5 F/L NO. 276-2 SEC. 1
TATUNG RD.,HSICHIN CITY
TAIPEI HSIEN 221 TW
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Contact BRIAN LAI
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 09/16/2009
Decision Date 03/11/2010
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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