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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K022981
Device Name INION CPS 2.5/2.8 SCREW
Applicant
Inion , Ltd.
Laakarinkatu2
Tampere,  FI FIN-33520
Applicant Contact HANNA MARTTILA
Correspondent
Inion , Ltd.
Laakarinkatu2
Tampere,  FI FIN-33520
Correspondent Contact Kati Marttinen
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
JEY  
Date Received09/09/2002
Decision Date 09/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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