Device Classification Name |
Plate, Cranioplasty, Preformed, Alterable
More FDA Info for this Device |
510(K) Number |
K170368 |
Device Name |
Plate, Cranioplasty, Preformed, Alterable |
Applicant |
Jeil Medical Corporation
55 Digital-ro, 34-gil
702, 703, 704, 705, 706, 804, 805, 807, 812-ho
Seoul 152-728 KR
Other 510(k) Applications for this Company
|
Contact |
Seungyong Lee
Other 510(k) Applications for this Contact |
Regulation Number |
882.5320
More FDA Info for this Regulation Number |
Classification Product Code |
GWO
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
02/06/2017 |
Decision Date |
09/11/2017 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
NE - Neurology |
Review Advisory Committee |
NE - Neurology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|