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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 K030519
Device Name WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS
Original Applicant
HAND BIOMECHANICS LAB, INC.
77 scripps dr., suite 104
sacramento,  CA  95825
Original Contact timothy r stallings
Regulation Number888.3040
Classification Product Code
JEC  
Date Received02/19/2003
Decision Date 06/10/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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