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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Non-Alterable
510(k) Number K252958
Device Name METICULY Patient-specific titanium mesh implant
Applicant
Meticuly Co., Ltd.
924 B Bldg., Rm. B116-118, B210-212
Soi Chula 7, Wang Mai, Pathum Wan
Bangkok,  TH 10330
Applicant Contact Lohwongwatana Peeranoot
Correspondent
Mdr Solutions Co., Ltd.
1435 Kanjanapisek Rd.
Bang Khae Nuea, Bang Khae
Bangkok,  TH 10160
Correspondent Contact Paweena U-Thainual
Regulation Number882.5330
Classification Product Code
GXN  
Date Received09/16/2025
Decision Date 01/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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