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FDA 510(k) Application Details - K032152
Device Classification Name
Alloy, Amalgam
More FDA Info for this Device
510(K) Number
K032152
Device Name
Alloy, Amalgam
Applicant
SOUTHERN DENTAL INDUSTRIES, INC.
729 N. ROUTE 83, SUITE 315
BENSENVILLE, IL 60106 US
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Contact
SAMANTHA J CHEETHAM
Other 510(k) Applications for this Contact
Regulation Number
872.3070
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Classification Product Code
EJJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/28/2003
Decision Date
08/06/2003
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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