FDA 510(k) Application Details - K100349

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K100349
Device Name Lenses, Soft Contact, Daily Wear
Applicant JOHNSON & JOHNSON VISION CARE, INC.
7500 CENTURION PKWY.
SUITE 100
JACKSONVILLE, FL 32256 US
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Contact CATHERINE DILLON
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 02/12/2010
Decision Date 05/21/2010
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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