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FDA 510(k) Application Details - K984090
Device Classification Name
Lenses, Soft Contact, Daily Wear
More FDA Info for this Device
510(K) Number
K984090
Device Name
Lenses, Soft Contact, Daily Wear
Applicant
SPECIALTY ULTRAVISION, INC.
307 ORCHARD CITY DR.
CAMPBELL, CA 95008 US
Other 510(k) Applications for this Company
Contact
IVALEE I COHEN
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
11/16/1998
Decision Date
07/07/1999
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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