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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 K021979
Device Name SMISSON STABILIZATION SYSTEM
Applicant
Smisson-Cartledge
3722 Ave., Sausalito
Irvine,  CA  92606
Applicant Contact GRACE HOLLAND
Correspondent
Smisson-Cartledge
3722 Ave., Sausalito
Irvine,  CA  92606
Correspondent Contact GRACE HOLLAND
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received06/17/2002
Decision Date 06/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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