Name: Predicase
Price: 199 USD

K-number	K043500
Device name	FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE
Applicant	Innospine, Inc.
Product code	BSP
Device class	Class II
Decision date	Apr 15, 2005
Decision	Substantially Equivalent
Regulation	868.5150

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Source

View the full FDA submission: accessdata.fda.gov

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FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE

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