K181382
Substantially EquivalentGuardianTM Burr Hole Cover System
- Applicant
- St Jude Medical
- Product 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.