FDA 510(k), K161457, XEN Glaucoma Treatment System
FDA 510(k), K161457, XEN Glaucoma Treatment System
Regular price
$149.00 USD
Regular price
Sale price
$149.00 USD
Unit price
/
per
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: 05/26/2016
Date Received: 11/21/2016
Decision Date: 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: 05/26/2016
Date Received: 11/21/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
View full details