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FDA 510(k) Application Details - K051203
Device Classification Name
Activator, Ultraviolet, For Polymerization
More FDA Info for this Device
510(K) Number
K051203
Device Name
Activator, Ultraviolet, For Polymerization
Applicant
MONITEX INDUSTRIAL CO., LTD.
6F, 70 GUANG-FU RD., SEC 1,
SAN-CHUNG CITY
TAIPEI 241-58 TW
Other 510(k) Applications for this Company
Contact
SHU-LUNG WANG
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
05/11/2005
Decision Date
05/25/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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