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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 K033112
Device Name WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS
Applicant
Hand Biomechanics Lab, Inc.
77 Scripps Dr., Suite 104
Sacramento,  CA  95825
Applicant Contact TIMOTHY R STALLINGS
Correspondent
Hand Biomechanics Lab, Inc.
77 Scripps Dr., Suite 104
Sacramento,  CA  95825
Correspondent Contact TIMOTHY R STALLINGS
Regulation Number888.3030
Classification Product Code
KTT  
Date Received09/30/2003
Decision Date 11/05/2003
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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