SENSIMED TRIGGERFISH
FDA 510(k) clearance DEN140017 · decided 2016-03-04
Clearance details
- K-number
- DEN140017
- Device name
- SENSIMED TRIGGERFISH
- Applicant
- Sensimed AG
- Decision
- Unknown
- Date received
- 2014-05-06
- Decision date
- 2016-03-04
- Days to decision
- 668 days
- Clearance type
- Direct
- Product code
- PLZ
- Device class
- 2
- Regulation number
- 886.1925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.