Name: Predicase
Price: 199 USD

K-number	K232245
Device name	VedDilator ^TM (3-Stage Balloon Dilation Catheter)
Applicant	Jiangsu Vedkang Medical Science and Technology Co., Ltd.
Product code	FGE
Device class	Class II
Decision date	Feb 15, 2024
Decision	Substantially Equivalent
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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VedDilator ^TM (3-Stage Balloon Dilation Catheter)

Everything you need for a 510(k) submission. Nothing you don't.