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FDA 510(k) Application Details - K080632
Device Classification Name
Lens, Contact, (Disposable)
More FDA Info for this Device
510(K) Number
K080632
Device Name
Lens, Contact, (Disposable)
Applicant
CLEARLAB SG PTE LTD.
806 KIMBALL AVENUE
GRAND JUNCTION, CO 81501 US
Other 510(k) Applications for this Company
Contact
MARTIN DALSING
Other 510(k) Applications for this Contact
Regulation Number
886.5925
More FDA Info for this Regulation Number
Classification Product Code
MVN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/05/2008
Decision Date
10/15/2008
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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