CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS

Device, Monitoring, Intracranial Pressure

Codman & Shurtleff, Inc.

The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Single And Double Lumen Skull Bolt Kits.

Pre-market Notification Details

Device IDK992591
510k NumberK992591
Device Name:CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
ClassificationDevice, Monitoring, Intracranial Pressure
Applicant Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
ContactJames M Flaherty
CorrespondentJames M Flaherty
Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
Product CodeGWM  
CFR Regulation Number882.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-02
Decision Date1999-10-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886704042501 K992591 000

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