FDA 510(k) Application Details - K110166

Device Classification Name Knife, Ophthalmic

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510(K) Number K110166
Device Name Knife, Ophthalmic
Applicant ALCON RESEARCH, LTD.
6201 SOUTH FREEWAY
FORT WORTH, TX 76134-2099 US
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Contact TONYA MORGAN
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Regulation Number 886.4350

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Classification Product Code HNN
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Date Received 01/20/2011
Decision Date 05/20/2011
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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