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FDA 510(k) Application Details - K172314
Device Classification Name
Lens, Contact (Other Material) - Daily
More FDA Info for this Device
510(K) Number
K172314
Device Name
Lens, Contact (Other Material) - Daily
Applicant
Art Optical Contact Lens Inc
3175 3 Mile Rd NW
Grand Rapids, MI 49534 US
Other 510(k) Applications for this Company
Contact
Mike Johnson
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
08/01/2017
Decision Date
09/20/2017
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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