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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 K210099
Device Name Meticuly Patient-Specific Titanium Mesh Implant
Applicant
Meticuly Co., Ltd.
32/77, Soi Samakkee 58/20, Samakkee Rd., Tasai
Muang Nonthaburi,  TH 11000
Applicant Contact Peeranoot Lohwongwatana
Correspondent
Meticuly Co., Ltd.
32/77, Soi Samakkee 58/20, Samakkee Rd., Tasai
Muang Nonthaburi,  TH 11000
Correspondent Contact Peeranoot Lohwongwatana
Regulation Number882.5330
Classification Product Code
GXN  
Date Received01/14/2021
Decision Date 12/21/2021
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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