Name: Predicase
Price: 199 USD

K-number	K212857
Device name	Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use
Applicant	Jiangsu Zhiyu Medical Instrument Co, Ltd.
Product code	FMF
Device class	Class II
Decision date	May 9, 2023
Decision	Substantially Equivalent
Regulation	880.5860

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Source

View the full FDA submission: accessdata.fda.gov

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Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use

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