Name: Predicase
Price: 199 USD

K-number	K211210
Device name	Sterile Auto-Disable Syringes with/without Needle for Single Use
Applicant	Azur Medical Company, Inc.
Product code	FMF
Device class	Class II
Decision date	Jan 27, 2022
Decision	Substantially Equivalent
Regulation	880.5860

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Sterile Auto-Disable Syringes with/without Needle for Single Use

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