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FDA 510(k) Application Details - K093751
Device Classification Name
Activator, Ultraviolet, For Polymerization
More FDA Info for this Device
510(K) Number
K093751
Device Name
Activator, Ultraviolet, For Polymerization
Applicant
GOOD DOCTORS CO., LTD.
5401 S. COTTONWOOD CT
GREENWOOD VILLAGE, CO 80121 US
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Contact
KEVIN WALLS, RAC
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Regulation Number
872.6070
More FDA Info for this Regulation Number
Classification Product Code
EBZ
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More FDA Info for this Product Code
Date Received
12/07/2009
Decision Date
02/24/2010
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
N
Expedited Review
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