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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 K150898
Device Name LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm
Applicant
MOLLER MEDICAL GMBH
WASSERKUPPENSTR.29-31
FULDA,  DE 36043
Applicant Contact JULIANE DRAGON
Correspondent
MOLLER MEDICAL GMBH
WASSERKUPPENSTR.29-31
FULDA,  DE 36043
Correspondent Contact JULIANE DRAGON
Regulation Number882.5550
Classification Product Code
JXG  
Date Received04/02/2015
Decision Date 12/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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