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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K080841
Device Name COSMIC SYSTEM
Applicant
Ulrich GmbH & Co. KG
754 Spirit 40 Park Dr.
St. Louis,  MO  63005
Applicant Contact MERLE SYMES
Correspondent
Ulrich GmbH & Co. KG
754 Spirit 40 Park Dr.
St. Louis,  MO  63005
Correspondent Contact MERLE SYMES
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received03/26/2008
Decision Date 07/23/2008
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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