Name: Predicase
Price: 199 USD

K-number	K030289
Device name	HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N
Applicant	Integra Lifesciences Corp.
Product code	JXG
Device class	Class II
Decision date	Feb 26, 2003
Decision	Substantially Equivalent
Regulation	882.5550

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Source

View the full FDA submission: accessdata.fda.gov

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HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N

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