FDA.reportPublic FDA data

510(k) K222164

Device
Visant Medical Canalicular Plug
Applicant
Visant Medical, Inc.
510(k) number
K222164
Product code
LZU
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-23
Date received
2022-07-21
Classification name
Plug, Punctum
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Vartan Ghazarossian
Address
801 Hermosa Way Menlo Park CA US 94025 94025

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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