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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 DRIVE
ST. LOUIS,  MO  63005
Applicant Contact MERLE SYMES
Correspondent
ULRICH GMBH & CO. KG
754 SPIRIT 40 PARK DRIVE
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
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