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FDA 510(k) Application Details - K093559
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K093559
Device Name
Powder, Porcelain
Applicant
SHOFU DENTAL CORP.
1225 STONE DR.
SAN MARCOS, CA 92078 US
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Contact
DAVID P MORAIS
Other 510(k) Applications for this Contact
Regulation Number
872.6660
More FDA Info for this Regulation Number
Classification Product Code
EIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/18/2009
Decision Date
03/03/2010
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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