K-number	K103531
Device name	PRESTIGE 24I; BIOLIS 24I; MGC 240
Applicant	Tokyo Boeki Medisys, Inc.
Product code	CFR
Device class	Class II
Decision date	Dec 1, 2011
Decision	Substantially Equivalent
Regulation	862.1345

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View the full FDA submission: accessdata.fda.gov

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PRESTIGE 24I; BIOLIS 24I; MGC 240

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