FDA 510(k) Application Details - K182902

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K182902
Device Name Lenses, Soft Contact, Daily Wear
Applicant Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099 US
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Contact Alicia Plesnarski
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 10/16/2018
Decision Date 12/11/2018
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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