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 STE 110 |
FULLERTON,
CA
92831
|
|
Correspondent Contact |
Priscilla Chung |
Regulation Number | 882.5330
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/21/2013 |
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
|
|
|