K-number	K212296
Device name	Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
Applicant	Fujifilm Corporation
Product code	FDS
Device class	Class II
Decision date	Aug 19, 2021
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2

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