K-number	K823255
Device name	NON-STERILE REUSABLE NEEDLES
Applicant	Vertex Medical Corp.
Product code	FMI
Device class	Class II
Decision date	Nov 22, 1982
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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NON-STERILE REUSABLE NEEDLES

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