K-number	K213015
Device name	DORA Disposable A.V. Fistula Needle Sets
Applicant	Bain Medical Equipment (Guangzhou) Co., Ltd.
Product code	FIE
Device class	Class II
Decision date	Apr 8, 2022
Decision	Substantially Equivalent
Regulation	876.5540

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Source

View the full FDA submission: accessdata.fda.gov

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DORA Disposable A.V. Fistula Needle Sets

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