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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
Applicant
FOURNITURES HOSPITALIERES INDUSTRIE
ZI DE KERNEVEZ-6 RUE NOBEL
QUIMPER,  FR 29000
Applicant Contact PATRICIA DONNARD
Correspondent
FOURNITURES HOSPITALIERES INDUSTRIE
ZI DE KERNEVEZ-6 RUE NOBEL
QUIMPER,  FR 29000
Correspondent Contact PATRICIA DONNARD
Regulation Number888.3040
Classification Product Code
MBI  
Date Received03/12/2012
Decision Date 03/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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