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FDA 510(k) Application Details - K243355
Device Classification Name
Table, Physical Therapy, Multi Function
More FDA Info for this Device
510(K) Number
K243355
Device Name
Table, Physical Therapy, Multi Function
Applicant
CERAGEM Co, Ltd.
10, Jeongja 1-gil, Seonggeo-eup, Seobuk-gu
Cheonan-si 31041 KR
Other 510(k) Applications for this Company
Contact
Choongwoo Lee
Other 510(k) Applications for this Contact
Regulation Number
890.5880
More FDA Info for this Regulation Number
Classification Product Code
JFB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/29/2024
Decision Date
11/27/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K243355
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