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FDA 510(k) Application Details - K031477
Device Classification Name
Lenses, Soft Contact, Daily Wear
More FDA Info for this Device
510(K) Number
K031477
Device Name
Lenses, Soft Contact, Daily Wear
Applicant
OCULAR SCIENCES, INC.
15825 SHADY GROVE RD, SUITE 30
ROCKVILLE, MD 20850 US
Other 510(k) Applications for this Company
Contact
RICHARD E LIPPMAN
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
05/09/2003
Decision Date
07/18/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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