FDA.reportPublic FDA data

510(k) K232938

Device
Traus SSG30 Surgical System
Applicant
Saeshin Precision Co., Ltd.
510(k) number
K232938
Product code
HBC
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-16
Date received
2023-09-20
Regulation
882.4360
Classification name
Motor, Drill, Electric
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gung San Nam
Address
# 52, Secheon-Ro 1-Gil, Dasa-Eup, Dalseong-Gun Daegu KR 42921 42921

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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