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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 K143523
Device Name Airlock osteosynthesis plate system
Applicant
Novastep
Eapace Performance Alphasis - Batiment C1-C2
Saint Gregoire,  FR 35769
Applicant Contact Gilles AUDIC
Correspondent
Novastep
Eapace Performance Alphasis - Batiment C1-C2
Saint Gregoire,  FR 35769
Correspondent Contact Gilles AUDIC
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/12/2014
Decision Date 04/06/2015
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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