FDA 510(k) Application Details - K994318

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K994318
Device Name Lenses, Soft Contact, Daily Wear
Applicant VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.
7500 CENTURION PKWY.
JACKSONVILLE, FL 32256 US
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Contact SHARON BRIGGS
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 12/22/1999
Decision Date 02/23/2000
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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