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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K120818
Device Name OTIS-C PLUS
Original Applicant
zi du monge
lourdes,  FR f 65100
Original Contact denis clement
Regulation Number888.3030
Classification Product Code
Subsequent Product Code
Date Received03/19/2012
Decision Date 04/19/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No