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FDA 510(k) Application Details - K171575
Device Classification Name
Lens, Contact (Other Material) - Daily
More FDA Info for this Device
510(K) Number
K171575
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
05/30/2017
Decision Date
10/24/2017
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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