Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover— 510(k) K152342

Substantially Equivalent

St 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.

Clearance details

Applicant: St Jude Medical
Product code: Code GXR
Advisory panel: Neurology
Date received: 2015-08-19
Decision date: 2016-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

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