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FDA 510(k) Application Details - K051010
Device Classification Name
Alloy, Amalgam
More FDA Info for this Device
510(K) Number
K051010
Device Name
Alloy, Amalgam
Applicant
SEPTODONT
1050 CONNECTICUT AVE., NW
WASHINGTON, DC 20036 US
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Contact
WAYNE H MATELSKI
Other 510(k) Applications for this Contact
Regulation Number
872.3070
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Classification Product Code
EJJ
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More FDA Info for this Product Code
Date Received
04/21/2005
Decision Date
05/02/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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