CODMAN HAKIM MICRO PRECISION VALVE

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 Codman Hakim Micro Precision Valve.

Pre-market Notification Details

Device IDK973774
510k NumberK973774
Device Name:CODMAN HAKIM MICRO PRECISION VALVE
ClassificationShunt, Central Nervous System And Components
Applicant JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
ContactJanet G Johnson
CorrespondentJanet G Johnson
JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-03
Decision Date1997-12-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10381780537373 K973774 000

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