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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Traction, Invasive
510(k) Number K984442
Device Name AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147
Applicant
Hand Biomechanics Lab, Inc.
77 Scripps Dr., Suite 104
Sacramento,  CA  95825
Applicant Contact TIMOTHY STALLINGS
Correspondent
Hand Biomechanics Lab, Inc.
77 Scripps Dr., Suite 104
Sacramento,  CA  95825
Correspondent Contact TIMOTHY STALLINGS
Regulation Number888.3040
Classification Product Code
JEC  
Date Received12/14/1998
Decision Date 02/12/1999
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
Recalls CDRH Recalls
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