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FDA 510(k) Application Details - K974599
Device Classification Name
Lenses, Soft Contact, Daily Wear
More FDA Info for this Device
510(K) Number
K974599
Device Name
Lenses, Soft Contact, Daily Wear
Applicant
OPTI-CENTRE LABORATORIES
623 GLACIER DR.
GRAND JUNCTION, CO 81503 US
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Contact
MARTIN DALSING
Other 510(k) Applications for this Contact
Regulation Number
886.5925
More FDA Info for this Regulation Number
Classification Product Code
LPL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/09/1997
Decision Date
03/02/1998
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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