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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K142111
Device Name ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE
Applicant
Novatsep
Espace Performance Alphasis - Batiment C1-C2
Saint Gregoire,  FR 35769
Applicant Contact GILLES AUDIC
Correspondent
Novatsep
Espace Performance Alphasis - Batiment C1-C2
Saint Gregoire,  FR 35769
Correspondent Contact GILLES AUDIC
Regulation Number888.3030
Classification Product Code
JDR  
Date Received08/04/2014
Decision Date 12/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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