Name: Predicase
Price: 199 USD

K-number	K201284
Device name	Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use
Applicant	Set Medikal Sanayi VE Ticaret Anonim Sirketi
Product code	FMF
Device class	Class II
Decision date	Dec 14, 2020
Decision	Substantially Equivalent
Regulation	880.5860

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Source

View the full FDA submission: accessdata.fda.gov

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Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use

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