NEUROGEN NERVE GUIDE

Cuff, Nerve

INTEGRA LIFESCIENCES CORP.

The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Neurogen Nerve Guide.

Pre-market Notification Details

Device IDK011168
510k NumberK011168
Device Name:NEUROGEN NERVE GUIDE
ClassificationCuff, Nerve
Applicant INTEGRA LIFESCIENCES CORP. 105 MORGAN LANE Plainsboro,  NJ  08536
ContactJudith E O'grady
CorrespondentJudith E O'grady
INTEGRA LIFESCIENCES CORP. 105 MORGAN LANE Plainsboro,  NJ  08536
Product CodeJXI  
CFR Regulation Number882.5275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-17
Decision Date2001-06-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10381780071860 K011168 000
10381780026471 K011168 000
10381780026488 K011168 000
10381780026495 K011168 000
10381780026501 K011168 000
10381780026518 K011168 000
10381780026525 K011168 000
10381780026532 K011168 000
10381780071822 K011168 000
10381780071839 K011168 000
10381780071846 K011168 000
10381780071853 K011168 000
10381780026464 K011168 000

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