Name: Predicase
Price: 199 USD

K-number	K113587
Device name	AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)
Applicant	Shantou Wealy Medical Instrument Co.,Ltd
Product code	MEG
Device class	Class II
Decision date	Feb 24, 2012
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 SYRINGE (WITH FIXED NEEDLE)

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