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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K122890
Device Name INION CPS ORBITAL PLATES
Applicant
Inion OY
Laakarinkatu 2
Tampere,  FI 33520
Applicant Contact KATI MARTTINEN
Correspondent
Inion OY
Laakarinkatu 2
Tampere,  FI 33520
Correspondent Contact Kati Marttinen
Regulation Number872.4760
Classification Product Code
JEY  
Date Received09/20/2012
Decision Date 01/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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