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FDA 510(k) Application Details - K233921
Device Classification Name
Chair, Dental, With Operative Unit
More FDA Info for this Device
510(K) Number
K233921
Device Name
Chair, Dental, With Operative Unit
Applicant
DENTIS CO., LTD.
99, Seongseoseo-Ro, Dalseo-Gu
Daegu 42718 KR
Other 510(k) Applications for this Company
Contact
Kim Kaon
Other 510(k) Applications for this Contact
Regulation Number
872.6250
More FDA Info for this Regulation Number
Classification Product Code
KLC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/13/2023
Decision Date
09/06/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K233921
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