Device Classification Name |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
More FDA Info for this Device |
510(K) Number |
K152158 |
Device Name |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
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 |
Jiwon KANG
Other 510(k) Applications for this Contact |
Regulation Number |
888.3030
More FDA Info for this Regulation Number |
Classification Product Code |
KTT
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
08/03/2015 |
Decision Date |
09/28/2015 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OR - Orthopedic |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|