FDA 510(k) Application Details - K142820

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K142820
Device Name Lenses, Soft Contact, Daily Wear
Applicant ABB Optical Group, LLC
1750 N. Loop Road, Ste. 150
Alameda, CA 94502 US
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Contact John Kenyon
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 09/30/2014
Decision Date 04/30/2015
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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