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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 K121248
Models 00002650, REF, 92007836, 00002672, 00002701, 00002911, REF, 92008568, 0002563
Device Name LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC
Original Applicant
MOLLER MEDICAL GMBH
1612 jenks drive
corona,  CA  92880
Original Contact grant geckeler
Regulation Number882.5550
Classification Product Code
JXG  
Date Received04/25/2012
Decision Date 12/13/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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