Name: Predicase
Price: 199 USD

K-number	K081404
Device name	SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT
Applicant	Spinal Integration, LLC
Product code	BSO
Device class	Class II
Decision date	Oct 21, 2008
Decision	Substantially Equivalent
Regulation	868.5120

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Source

View the full FDA submission: accessdata.fda.gov

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SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT

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