Name: Predicase
Price: 199 USD

K-number	K142553
Device name	UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle
Applicant	Unisis Corp.
Product code	BSP
Device class	Class II
Decision date	Jan 14, 2015
Decision	Substantially Equivalent
Regulation	868.5150

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Source

View the full FDA submission: accessdata.fda.gov

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UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle

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