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. Device class: 2.
Clearance details
- Applicant
- St Jude Medical
- Product code
- Code GXR
- Device class
- Class 2
- Regulation
- 21 CFR 882.5250
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Plano, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.