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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 K214109
Device Name PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
Applicant
Kontour(Xi’an) Medical Technology Co., Ltd.
No.6, Qinling Avenue, Caotang Technology Industries Base
Xi’an High-tech Zone,
Xi'an,  CN 710304
Applicant Contact Rongrong Cong
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713A, 17th Floor, Block A, Zhongguan Times Square
Nanshan District
Shenzhen,  CN 518100
Correspondent Contact Joyce Yang
Regulation Number882.5330
Classification Product Code
GXN  
Date Received12/29/2021
Decision Date 10/28/2022
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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