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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 K120740
Device Name COLS® FIXATION SYSTEM
Original Applicant
FOURNITURES HOSPITALIERES INDUSTRIE
zi de kernevez-6 rue nobel
quimper,  FR 29000
Original Contact patricia donnard
Regulation Number888.3040
Classification Product Code
MBI  
Date Received03/12/2012
Decision Date 03/05/2013
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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