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FDA 510(k) Application Details - K973247
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K973247
Device Name
Powder, Porcelain
Applicant
SHOFU DENTAL CORP.
4024 BOHANNON DR.
MENLO PARK, CA 94025-1096 US
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Contact
THOMAS D YANKELITIS
Other 510(k) Applications for this Contact
Regulation Number
872.6660
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Classification Product Code
EIH
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More FDA Info for this Product Code
Date Received
08/29/1997
Decision Date
10/16/1997
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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