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FDA 510(k) Application Details - K103132
Device Classification Name
Lenses, Soft Contact, Daily Wear
More FDA Info for this Device
510(K) Number
K103132
Device Name
Lenses, Soft Contact, Daily Wear
Applicant
OCULUS PRIVATE LIMITED
5401 S COTTONWOOD CT.
GREENWOOD VILLAGE, CO 80121 US
Other 510(k) Applications for this Company
Contact
Kevin Walls
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
10/25/2010
Decision Date
09/08/2011
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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