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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 K864676
Device Name HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM
Applicant
AMERICAN V. MUELLER
6600 W. TOUHY
CHICAGO,  IL  60648
Applicant Contact MATTHEW NOWLAND
Correspondent
AMERICAN V. MUELLER
6600 W. TOUHY
CHICAGO,  IL  60648
Correspondent Contact MATTHEW NOWLAND
Regulation Number882.5550
Classification Product Code
JXG  
Date Received12/02/1986
Decision Date 12/29/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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