K-number	K192310
Device name	Flap Fixator, Burr Hole Cover
Applicant	Ossaware Biotech Co., Ltd.
Product code	GXR
Device class	Class II
Decision date	Jun 3, 2020
Decision	Substantially Equivalent
Regulation	882.5250

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Source

View the full FDA submission: accessdata.fda.gov

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Flap Fixator, Burr Hole Cover

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