K-number	K191357
Device name	Flexible HD Cysto-Urethroscope System
Applicant	KARL STORZ Endoscopy-America, Inc.
Product code	FAJ
Device class	Class II
Decision date	Sep 18, 2019
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Flexible HD Cysto-Urethroscope System

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