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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 K182758
Device Name MCI - CMF System
Applicant
Mci Medical Concept Innovation, Inc.
4592 N. Hiatus Rd.
Sunrise,  FL  33351
Applicant Contact Carlos Lacerda
Correspondent
Passarini Regulatory Affairs of America, LLC
201 Biscayne Blvd., Suite 1200
Miami,  FL  33131
Correspondent Contact Janine Treter
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Code
DZL  
Date Received09/28/2018
Decision Date 12/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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