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510(k) K253373

Device
Southern Craniomaxillofacial (CMF) System
Applicant
Southern Medical (Pty) , Ltd.
510(k) number
K253373
Product code
JEY
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-19
Date received
2025-09-30
Regulation
872.4760
Classification name
Plate, Bone
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Dalene Styger
Address
55 Regency Dr. Rte. 21 Corporate Park Irene ZA 0062 0062

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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