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FDA 510(k) Application Details - K963013
Device Classification Name
Lenses, Soft Contact, Daily Wear
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510(K) Number
K963013
Device Name
Lenses, Soft Contact, Daily Wear
Applicant
COOPERVISION, INC.
711 NORTH RD.
SCOTTSVILLE, NY 14546 US
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Contact
BERNARD F HALLATT
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
07/30/1996
Decision Date
12/19/1997
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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