510(k) DEN140022
- Device
- GLAUCOMA COMPANION
- Applicant
- Innovatex, Inc.
- 510(k) number
- DEN140022
- Product code
- PLX
- Decision
- Unknown (DENG)
- Decision date
- 2016-04-20
- Date received
- 2014-07-18
- Regulation
- 886.5838
- Classification name
- Tear Duct Occluder
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- STEPHEN C CHEN
- Address
- 150 Buckskin Dr. Weston MA US 02493 02493
FDA Registration Numbers#
- 3042228518
Source Documents#
510(k) summary PDF not indicated by FDA