K-number	K103582
Device name	KELYNIAM CUSTOM SKULL IMPLANT (CSI)
Applicant	Kelyniam Global, Inc.
Product code	GXN
Device class	Class II
Decision date	Apr 14, 2011
Decision	Substantially Equivalent
Regulation	882.5330

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View the full FDA submission: accessdata.fda.gov

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KELYNIAM CUSTOM SKULL IMPLANT (CSI)

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