FDA 510(k) Application Details - K041008

Device Classification Name Accessories, Soft Lens Products

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510(K) Number K041008
Device Name Accessories, Soft Lens Products
Applicant OPTICS LABORATORY, INC.
5408 INTERSTATE DRIVE
SHREVEPORT, LA 71109 US
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Contact J.R. CHEN
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Regulation Number 886.5928

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Classification Product Code LPN
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Date Received 04/19/2004
Decision Date 07/01/2005
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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