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FDA 510(k), K161457, XEN Glaucoma Treatment System
FDA 510(k), K161457, XEN Glaucoma Treatment System
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510(K) Number: K161457
Device Name: XEN Glaucoma Treatment System
Manufacturer: Barbara A. Niksch
Device Classification Name: Implant, Eye Valve
Regulation Number: KYF
Classification Product Code: KXA
Date Received: 05/26/2016
Decision Date: 11/21/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
Device Name: XEN Glaucoma Treatment System
Manufacturer: Barbara A. Niksch
Device Classification Name: Implant, Eye Valve
Regulation Number: KYF
Classification Product Code: KXA
Date Received: 05/26/2016
Decision Date: 11/21/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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