SIPHONGUARD CSF CONTROL DEVICE

Shunt, Central Nervous System And Components

JOHNSON & JOHNSON PROFESSIONALS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Siphonguard Csf Control Device.

Pre-market Notification Details

Device IDK992173
510k NumberK992173
Device Name:SIPHONGUARD CSF CONTROL DEVICE
ClassificationShunt, Central Nervous System And Components
Applicant JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
ContactLaura O'grady
CorrespondentLaura O'grady
JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-28
Decision Date2000-04-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10381780519416 K992173 000

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