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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
Other 510(k) Applications for this Contact
Regulation Number
886.5925
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Classification Product Code
LPL
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More FDA Info for this Product Code
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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