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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K113346
Device Name NEON SYSTEM
Applicant
Ulrich GmbH & Co. KG
612 Trade Center Blvd.
Chesterfield,  MO  63005
Applicant Contact HANS STOVER
Correspondent
Ulrich GmbH & Co. KG
612 Trade Center Blvd.
Chesterfield,  MO  63005
Correspondent Contact HANS STOVER
Regulation Number888.3050
Classification Product Code
KWP  
Date Received11/14/2011
Decision Date 02/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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