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FDA 510(k) Application Details - K223709
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K223709
Device Name
Arthroscope
Applicant
Jiangsu Changmei Medtech Co., Ltd.
No.27, Xinke West Road, Luoyang Town
Wujin District
Changzhou 213104 CN
Other 510(k) Applications for this Company
Contact
Yang Lifan
Other 510(k) Applications for this Contact
Regulation Number
888.1100
More FDA Info for this Regulation Number
Classification Product Code
HRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/12/2022
Decision Date
08/16/2023
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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