Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K232593
Device Classification Name
Prosthesis, Chin, Internal
More FDA Info for this Device
510(K) Number
K232593
Device Name
Prosthesis, Chin, Internal
Applicant
Keosan Trading Co.
#805, #806, Human Teco B/D, 57, Achasan-ro 17-gil
Seongdong-gu
Seoul KR
Other 510(k) Applications for this Company
Contact
Priscilla Chung
Other 510(k) Applications for this Contact
Regulation Number
878.3550
More FDA Info for this Regulation Number
Classification Product Code
FWP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/25/2023
Decision Date
11/22/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K232593
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact