K-number	K183332
Device name	BRAXX Esophageal Brachytherapy Applicator
Applicant	Braxx Biotech Co., Ltd.
Product code	JAQ
Device class	Class II
Decision date	Apr 16, 2019
Decision	Substantially Equivalent
Regulation	892.5700

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Source

View the full FDA submission: accessdata.fda.gov

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BRAXX Esophageal Brachytherapy Applicator

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BRAXX Esophageal Brachytherapy Applicator