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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K061748
Device Name FRAGMENT PLATE SYSTEM
Applicant
Hand Innovations, LLC
700 Orthopaedic Dr.
P.O. Box 988
Warsaw,  IN  46581
Applicant Contact NATALIE S HECK
Correspondent
Hand Innovations, LLC
700 Orthopaedic Dr.
P.O. Box 988
Warsaw,  IN  46581
Correspondent Contact NATALIE S HECK
Regulation Number888.3030
Classification Product Code
KTT  
Date Received06/21/2006
Decision Date 07/17/2006
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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