FDA 510(k) Application Details - K173538

Device Classification Name Case, Contact Lens

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510(K) Number K173538
Device Name Case, Contact Lens
Applicant Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099 US
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Contact Katryna Warren
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Regulation Number 886.5928

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Classification Product Code LRX
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Date Received 11/15/2017
Decision Date 12/04/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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