Name: Predicase
Price: 199 USD

K-number	K141640
Device name	AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE
Applicant	Shantou Wealy Medical Instrument Co.,Ltd
Product code	MEG
Device class	Class II
Decision date	Nov 19, 2014
Decision	Substantially Equivalent
Regulation	880.5860

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Source

View the full FDA submission: accessdata.fda.gov

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AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE

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