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510(k) K230690

Device
Tandry Locking Plate System
Applicant
Microware Precision Co., Ltd.
510(k) number
K230690
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-17
Date received
2023-03-13
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Harrison Du
Address
# 12, Keyuan 2nd Rd., Situn District, Taichung City TW 40763 40763

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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