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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spine, Plate, Laminoplasty, Metal
510(k) Number K252930
Device Name AQUA Laminoplasty Systems
Applicant
ZheJiang Decans Medical Devices Co., Ltd.
#2836 Xincheng Ave., Gaozhao St.
Xiuzhou District
Jiaxing,  CN 314031
Applicant Contact Haifeng Liu
Correspondent
ZheJiang Decans Medical Devices Co., Ltd.
#2836 Xincheng Ave., Gaozhao St.
Xiuzhou District
Jiaxing,  CN 314031
Correspondent Contact Haifeng Liu
Regulation Number888.3050
Classification Product Code
NQW  
Date Received09/15/2025
Decision Date 05/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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