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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name shunt, central nervous system and components
510(k) Number K031303
Device Name AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
Applicant
AESCULAP, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Applicant Contact MATTHEW M HULL
Correspondent
AESCULAP, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Correspondent Contact MATTHEW M HULL
Regulation Number882.5550
Classification Product Code
JXG  
Date Received04/24/2003
Decision Date 06/04/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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