FDA 510(k) Application Details - K052290

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K052290
Device Name Lenses, Soft Contact, Daily Wear
Applicant CLEARLAB PTE LTD.
2214 SANFORD DRIVE, B7
GRAND JUNCTION, CO 81505 US
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Contact MARTIN DALSING
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 08/23/2005
Decision Date 05/15/2006
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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