K-number	K181382
Device name	GuardianTM Burr Hole Cover System
Applicant	St Jude Medical
Product code	GXR
Device class	Class II
Decision date	Jul 20, 2018
Decision	Substantially Equivalent
Regulation	882.5250

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Source

View the full FDA submission: accessdata.fda.gov

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GuardianTM Burr Hole Cover System

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