Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover— 510(k) K152342
Substantially EquivalentSt Jude Medical
FDA 510(k) clearance K152342 for Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover, Substantially Equivalent on 2016-06-09. 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
- Traditional
- Location
- Plano, TX, US
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More clearances from St Jude Medical
view allData sourced from openFDA. This site is unofficial and independent of the FDA.