FDA 510(k) Application Details - K110221

Device Classification Name Accessories, Soft Lens Products

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510(K) Number K110221
Device Name Accessories, Soft Lens Products
Applicant OPTICS LABORATORY, INC
9480 TELSTAR AVE
SUITE 3
EL MONTE, CA 91731-2988 US
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Contact PATRICIA CHIU
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Regulation Number 886.5928

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Classification Product Code LPN
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Date Received 01/25/2011
Decision Date 11/01/2011
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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