K-number	K223022
Device name	SC HONKYTONK PTCA Balloon Dilatation Catheter
Applicant	Sino Medical Sciences Technology, Inc.
Product code	LOX
Device class	Class II
Decision date	Feb 15, 2023
Decision	Substantially Equivalent
Regulation	870.5100

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Source

View the full FDA submission: accessdata.fda.gov

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SC HONKYTONK PTCA Balloon Dilatation Catheter

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