K-number	K133046
Device name	OMNIPORE CUSTOMIZED SURGICAL IMPLANTS
Applicant	Matrix Surgical Holdings, LLC/Matrix Surgical USA
Product code	KKY
Device class	Class II
Decision date	May 14, 2014
Decision	Substantially Equivalent
Regulation	878.3500

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Source

View the full FDA submission: accessdata.fda.gov

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OMNIPORE CUSTOMIZED SURGICAL IMPLANTS

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