FDA 510(k) Application Details - K950294

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K950294
Device Name Lenses, Soft Contact, Daily Wear
Applicant FLEXLENS, INC.
2890 SOUTH TEJON ST.
ENGLEWOOD, CO 80110 US
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Contact DAVID J DOUGHERTY
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 01/25/1995
Decision Date 04/11/1996
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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