CODMAN INTRACRANIAL BOLT

Device, Monitoring, Intracranial Pressure

JOHNSON & JOHNSON PROFESSIONALS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Codman Intracranial Bolt.

Pre-market Notification Details

Device IDK974088
510k NumberK974088
Device Name:CODMAN INTRACRANIAL BOLT
ClassificationDevice, Monitoring, Intracranial Pressure
Applicant JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
ContactJames M Flaherty Jr.
CorrespondentJames M Flaherty Jr.
JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeGWM  
CFR Regulation Number882.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-30
Decision Date1998-01-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886704048626 K974088 000

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