Device Classification Name |
Plate, Bone
|
510(k) Number |
K182758 |
Device Name |
MCI - CMF System |
Applicant |
MCI Medical Concept Innovation Inc. |
4592 North Hiatus Road |
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 Number | 872.4760
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/28/2018 |
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
|
|
|