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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 Intervertebral Body
510(k) Number K101353
Device Name GOLDEN GATE ANTERIOR PLATE SYSTEM
Applicant
Ulrich GmbH & Co. KG
754 Spirit 40 Park Dr.
St. Louis,  MO  63005
Applicant Contact HANS STOVER
Correspondent
Ulrich GmbH & Co. KG
754 Spirit 40 Park Dr.
St. Louis,  MO  63005
Correspondent Contact HANS STOVER
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received05/14/2010
Decision Date 02/04/2011
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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