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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 K060283
Device Name TRANSET SYSTEM
Applicant
Bonutti Research, Inc.
2600 S. Raney
P.O. Box 1367
Effingham,  IL  62401
Applicant Contact PATRICK BALSMANN
Correspondent
Bonutti Research, Inc.
2600 S. Raney
P.O. Box 1367
Effingham,  IL  62401
Correspondent Contact PATRICK BALSMANN
Regulation Number888.3040
Classification Product Code
HTY  
Date Received02/03/2006
Decision Date 02/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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