FDA 510(k) Application Details - K982344

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K982344
Device Name Lenses, Soft Contact, Daily Wear
Applicant WESLEY JESSEN CORP.
333 E. HOWARD AVE.
DES PLAINES, IL 60018-5903 US
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Contact JOSEPH FOOS
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 07/06/1998
Decision Date 12/22/1998
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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