K-number	K152257
Device name	Fujifilm Duodenoscope Model ED-530XT
Applicant	Fujifilm Medical Systems U.S.A, Inc.
Product code	FDT
Device class	Class II
Decision date	Jul 21, 2017
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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Fujifilm Duodenoscope Model ED-530XT

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