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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 K130447
Device Name SPEEDY FLAP SYSTEM
Applicant
Jeil Medical Corporation
#702, Kolon Science Valley 2nd
811, Guro-Dong, Guro-Gu
Seoul,  KR 152-050
Applicant Contact Jieun Kim
Correspondent
Lk Consulting Group Usa, Inc.
2651 E. Chapman Ave., Suite 110
Fullerton,  CA  92831
Correspondent Contact Priscilla Chung
Regulation Number882.5330
Classification Product Code
GXN  
Subsequent Product Code
GXR  
Date Received02/21/2013
Decision Date 12/22/2014
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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