EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS

Shunt, Central Nervous System And Components

INTEGRA NEUROCARE LLC.

The following data is part of a premarket notification filed by Integra Neurocare Llc. with the FDA for External Csf Drainage Management Systems.

Pre-market Notification Details

Device IDK972994
510k NumberK972994
Device Name:EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS
ClassificationShunt, Central Nervous System And Components
Applicant INTEGRA NEUROCARE LLC. 8401 102ND ST. SUITE 200-P.O. BOX 390 Pleasant Prairie,  WI  53150 -0390
ContactLori L Hays
CorrespondentLori L Hays
INTEGRA NEUROCARE LLC. 8401 102ND ST. SUITE 200-P.O. BOX 390 Pleasant Prairie,  WI  53150 -0390
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-12
Decision Date1997-11-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10381780072393 K972994 000
10381780537519 K972994 000
10381780537526 K972994 000
10381780542193 K972994 000
10381780071099 K972994 000
10381780071648 K972994 000
30381780071666 K972994 000
10381780071693 K972994 000
10381780071709 K972994 000
10381780071990 K972994 000
10381780072164 K972994 000
10381780537502 K972994 000

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