K-number	K230705
Device name	POT PTCA Balloon Dilatation Catheter
Applicant	Brosmed Medical Co., Ltd.
Product code	LOX
Device class	Class II
Decision date	Apr 11, 2023
Decision	Substantially Equivalent
Regulation	870.5100

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Source

View the full FDA submission: accessdata.fda.gov

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POT PTCA Balloon Dilatation Catheter

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