GLAUCOMA COMPANION
FDA 510(k) clearance DEN140022 · decided 2016-04-20
Clearance details
- K-number
- DEN140022
- Device name
- GLAUCOMA COMPANION
- Applicant
- Innovatex, Inc.
- Decision
- Unknown
- Date received
- 2014-07-18
- Decision date
- 2016-04-20
- Days to decision
- 642 days
- Clearance type
- Direct
- Product code
- PLX
- Device class
- 1
- Regulation number
- 886.5838
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Weston, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.