FDA 510(k) Application Details - K040839

Device Classification Name Products, Contact Lens Care, Rigid Gas Permeable

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510(K) Number K040839
Device Name Products, Contact Lens Care, Rigid Gas Permeable
Applicant ADVANCED MEDICAL OPTICS, INC.
1700 E. ST. ANDREW PLACE
P.O. BOX 25162
SANTA ANA, CA 92705-4933 US
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Contact PAUL J NOWACKI
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Regulation Number 886.5918

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Classification Product Code MRC
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Date Received 03/31/2004
Decision Date 10/19/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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