Name: Predicase
Price: 199 USD

K-number	K191684
Device name	MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
Applicant	Integra LifeSciences Corporation
Product code	JXG
Device class	Class II
Decision date	Oct 11, 2019
Decision	Substantially Equivalent
Regulation	882.5550

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Source

View the full FDA submission: accessdata.fda.gov

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MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System

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