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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, bone
510(k) Number K180204
Device Name CranioMaxillofacial Fixation (CMF) System - CMF Visionare
Visionare LLC
12251 Towne Lake Drive
Fort Meyers,  FL  33913
Applicant Contact Mariane de Oliveira Quinzani
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego,  CA  92130
Correspondent Contact Kevin Thomas
Regulation Number872.4760
Classification Product Code
Subsequent Product Code
Date Received01/24/2018
Decision Date 12/28/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No