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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K232889
Device Name METICULY Patient-specific titanium maxillofacial 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 Peeranoot Lohwongwatana
Correspondent
Mdr Solutions Co., Ltd.
1435 Kanjanapisek Rd.
Bang Khae Nuea, Bang Khae
Bangkok,  TH 10160
Correspondent Contact Paweena U-Thainual
Regulation Number872.4760
Classification Product Code
JEY  
Date Received09/18/2023
Decision Date 04/30/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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