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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
Applicant
HAND BIOMECHANICS LAB, INC.
77 scripps dr., suite 104
sacramento,  CA  95825
Contact timothy r stallings
Regulation Number888.3040
Classification Product Code
JEC  
Date Received02/19/2003
Decision Date 06/10/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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