FDA 510(k) Application Details - K200243

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K200243
Device Name Lenses, Soft Contact, Daily Wear
Applicant Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway, Suite 100
Jacksonville, FL 32256 US
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Contact Scott Durland
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 01/31/2020
Decision Date 03/17/2020
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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