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FDA 510(k) Application Details - K220826
Device Classification Name
Activator, Ultraviolet, For Polymerization
More FDA Info for this Device
510(K) Number
K220826
Device Name
Activator, Ultraviolet, For Polymerization
Applicant
Foshan COXO Medical Instrument Co., Ltd.
BLDG 4, District A, Guangdong New Light Source Industrial
Base, South of Luocun Avenue
Nanhai District, Foshan 528226 CN
Other 510(k) Applications for this Company
Contact
Yongjian Zheng
Other 510(k) Applications for this Contact
Regulation Number
872.6070
More FDA Info for this Regulation Number
Classification Product Code
EBZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/22/2022
Decision Date
12/08/2022
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
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