Name: Predicase
Price: 199 USD

K-number	K031173
Device name	NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013
Applicant	Needle Tech Products, Inc.
Product code	GDF
Device class	Class I
Decision date	Jul 23, 2003
Decision	Substantially Equivalent
Regulation	878.4800

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Source

View the full FDA submission: accessdata.fda.gov

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NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013

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