K-number	K133972
Device name	ASPIRE CRISTALLE
Applicant	Fujifilm Medical Systems U.S.A, Inc.
Product code	MUE
Device class	Class II
Decision date	Mar 25, 2014
Decision	Substantially Equivalent
Regulation	892.1715

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Source

View the full FDA submission: accessdata.fda.gov

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ASPIRE CRISTALLE

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