K-number	K223709
Device name	Kyphoplasty Balloon Catheter
Applicant	Jiangsu Changmei Medtech Co., Ltd.
Product code	HRX
Device class	Class II
Decision date	Aug 16, 2023
Decision	Substantially Equivalent
Regulation	888.1100

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View the full FDA submission: accessdata.fda.gov

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Kyphoplasty Balloon Catheter

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