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FDA 510(k) Application Details - K203523
Device Classification Name
Fastener, Fixation, Biodegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K203523
Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Applicant
AJU Pharm Co., Ltd.
A-207, 697, Pangyo-ro
Seongnam-si 13511 KR
Other 510(k) Applications for this Company
Contact
Kim Tae Hoon
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
MAI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/01/2020
Decision Date
12/25/2021
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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