FDA 510(k) Application Details - K023791

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K023791
Device Name Lenses, Soft Contact, Daily Wear
Applicant SOFTFOCAL COMPANY, INC.
69 SULLIVAN DR.
MORAGA, CA 94556 US
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Contact ROBERT B MANDELL
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 11/13/2002
Decision Date 01/10/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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