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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K242814
Device Name Tandry Q-Locking Plate System
Applicant
Microware Precision Co., Ltd.
# 12, Keyuan 2nd Rd., Situn District,
Taichung City,  TW 40763
Applicant Contact Harrison Du
Correspondent
Microware Precision Co., Ltd.
# 12, Keyuan 2nd Rd., Situn District,
Taichung City,  TW 40763
Correspondent Contact Harrison Du
Regulation Number888.3030
Classification Product Code
HRS  
Date Received09/18/2024
Decision Date 11/14/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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