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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fastener, fixation, biodegradable, soft tissue
510(k) Number K031519
Device Name CUFFLOK ANCHOR
Original Applicant
MITEK WORLDWIDE
a johnson & johnson company
249 vanderbilt avenue
norwood,  MA  02062
Original Contact ruth c forstadt
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
GAT  
Date Received05/19/2003
Decision Date 06/06/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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