Name: Predicase
Price: 199 USD

K-number	K010038
Device name	NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE
Applicant	Cambridge Marketing, Inc.
Product code	FMI
Device class	Class II
Decision date	Jan 24, 2001
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE

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