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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, nondegradable, soft tissue
510(k) Number K120096
Device Name MULTIFIX P KNOTLESS FIXATION DEVICE
Original Applicant
ARTHROCARE CORPORATION
7000 west william cannon drive
austin,  TX  78735
Original Contact cheryl frederick
Regulation Number888.3040
Classification Product Code
MBI  
Date Received01/12/2012
Decision Date 03/27/2012
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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