M. Blue Adjustable Shunt System

Shunt, Central Nervous System And Components

Aesculap, Inc.

The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for M. Blue Adjustable Shunt System.

Pre-market Notification Details

Device IDK192266
501k NumberK192266
Device Name:M. Blue Adjustable Shunt System
ClassificationShunt, Central Nervous System And Components
Applicant Aesculap, Inc. 3773 Corporate Parkway Center Valley,  PA  18034
ContactKathy A Racosky
CorrespondentKathy A Racosky
Aesculap, Inc. 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
501k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-21
Decision Date2019-11-21

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