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FDA 510(k) Application Details - K032165
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K032165
Device Name
Powder, Porcelain
Applicant
SHOFU DENTAL CORP.
1225 STONE DR.
SAN MARCOS, CA 92078 US
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Contact
ROBERT NOBLE
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
07/15/2003
Decision Date
09/16/2003
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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