K152342

Substantially Equivalent

Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover

Applicant: St Jude Medical
Product 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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