HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM

Shunt, Central Nervous System And Components

AMERICAN V. MUELLER

The following data is part of a premarket notification filed by American V. Mueller with the FDA for Heyer-schulte Hermetic External Csf Drain. System.

Pre-market Notification Details

Device IDK864676
510k NumberK864676
Device Name:HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM
ClassificationShunt, Central Nervous System And Components
Applicant AMERICAN V. MUELLER 6600 W. TOUHY Chicago,  IL  60648
ContactMatthew Nowland
CorrespondentMatthew Nowland
AMERICAN V. MUELLER 6600 W. TOUHY Chicago,  IL  60648
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-02
Decision Date1986-12-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10381780072386 K864676 000
30381780071659 K864676 000
10381780023937 K864676 000

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