FDA 510(k) Application Details - K180972
Device Classification Name |
Plate, Fixation, Bone
More FDA Info for this Device |
510(K) Number |
K180972 |
Device Name |
Plate, Fixation, Bone |
Applicant |
Jeil Medical Corporation
702,703,704,705,706,804,805,807,812,815-ho,55
Digital-ro34-gil, Guro-gu
Seoul 08378 KR
Other 510(k) Applications for this Company
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Contact |
Seungyong Lee
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 |
04/13/2018 |
Decision Date |
10/03/2018 |
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 |
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