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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K092011
Device Name NORM SPINAL SYSTEM
Applicant
NORM TIBBI URUNLER ITHALAT IHRACAT SANAYI VE TICAR
1CADDE NO:5/1 BALGAT
ANKARA,  TR 06520
Applicant Contact NURAY DOGAN
Correspondent
NORM TIBBI URUNLER ITHALAT IHRACAT SANAYI VE TICAR
1CADDE NO:5/1 BALGAT
ANKARA,  TR 06520
Correspondent Contact NURAY DOGAN
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received07/06/2009
Decision Date 10/28/2009
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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