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FDA 510(k) Application Details - K080193
Device Classification Name
Lens, Contact (Other Material) - Daily
More FDA Info for this Device
510(K) Number
K080193
Device Name
Lens, Contact (Other Material) - Daily
Applicant
Synergeyes, Inc.
15825 SHADY GROVE ROAD
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
886.5916
More FDA Info for this Regulation Number
Classification Product Code
HQD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/25/2008
Decision Date
03/05/2008
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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