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FDA 510(k) Application Details - K212631
Device Classification Name
Lens, Contact (Other Material) - Daily
More FDA Info for this Device
510(K) Number
K212631
Device Name
Lens, Contact (Other Material) - Daily
Applicant
Contamac Ltd.
Carlton House Shire Hill
Saffron Walden CB11 3AU GB
Other 510(k) Applications for this Company
Contact
Rob McGregor
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
08/19/2021
Decision Date
03/17/2022
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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