K-number	K211349
Device name	Selebrek PTCA Balloon Dilatation Catheter
Applicant	Kossel Medtech (Suzhou) Co., Ltd.
Product code	LOX
Device class	Class II
Decision date	Jan 7, 2022
Decision	Substantially Equivalent
Regulation	870.5100

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Source

View the full FDA submission: accessdata.fda.gov

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Selebrek PTCA Balloon Dilatation Catheter

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