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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 K192356
Device Name Airlock Centrolock Osteosynthesis Implant System
Applicant
Novastep
Espace Performance Iii- Batiment P
Saint-Gregoire,  FR 35769
Applicant Contact Gilles Audic
Correspondent
Novastep
Espace Performance Iii- Batiment P
Saint-Gregoire,  FR 35769
Correspondent Contact Gilles Audic
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/29/2019
Decision Date 12/14/2019
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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