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510(k) K231520

Device
tmCMF Solution
Applicant
Techmah Cmf
510(k) number
K231520
Product code
DZJ
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-02
Date received
2023-05-25
Regulation
872.4120
Classification name
Driver, Wire, And Bone Drill, Manual
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Mohamed Mahfouz
Address
2240 Sutherland Ave., Suite 2 Knoxville TN US 37919 37919

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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