GuardianTM Burr Hole Cover System— 510(k) K181382
Substantially EquivalentSt Jude Medical
FDA 510(k) clearance K181382 for GuardianTM Burr Hole Cover System, Substantially Equivalent on 2018-07-20. Applicant: St Jude Medical.
Clearance details
- Applicant
- St Jude Medical
- Product code
- Code GXR
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Plano, TX, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.