Device Classification Name |
Plate, Bone
More FDA Info for this Device |
510(K) Number |
K150965 |
Device Name |
Plate, Bone |
Applicant |
Jeil Medical Corporation
702, 703, 704, 705, 706, 804, 805,807,812-ho ,55,
Digital-ro34-gil, Guro-gu
Seoul-City 152-728 KR
Other 510(k) Applications for this Company
|
Contact |
Jieun KIM
Other 510(k) Applications for this Contact |
Regulation Number |
872.4760
More FDA Info for this Regulation Number |
Classification Product Code |
JEY
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
04/10/2015 |
Decision Date |
09/17/2015 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
DE - Dental |
Review Advisory Committee |
DE - Dental |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|