FDA 510(k) Application Details - K193616
Device Classification Name |
Plate, Fixation, Bone
More FDA Info for this Device |
510(K) Number |
K193616 |
Device Name |
Plate, Fixation, Bone |
Applicant |
Jeil Medical Corporation
702, 703, 704, 705, 706, 804, 805,807,812-ho ,55,
Digital-ro34-gil, Guro-gu
Seoul 08378 KR
Other 510(k) Applications for this Company
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Contact |
Jonghwan Kim
Other 510(k) Applications for this Contact |
Regulation Number |
888.3030
More FDA Info for this Regulation Number |
Classification Product Code |
HRS
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
12/26/2019 |
Decision Date |
03/04/2020 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OR - Orthopedic |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
Summary |
Type |
Special |
Reviewed By Third Party |
N |
Expedited Review |
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