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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K133932
Device Name INION FREEDOMPIN
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 Number888.3040
Classification Product Code
HTY  
Date Received12/23/2013
Decision Date 04/11/2014
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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