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FDA 510(k) Application Details - K002811
Device Classification Name
Alloy, Amalgam
More FDA Info for this Device
510(K) Number
K002811
Device Name
Alloy, Amalgam
Applicant
NORDISKA DENTAL AB
P.O. BOX 435
LYNWOOD, WA 98046 US
Other 510(k) Applications for this Company
Contact
RICHARD KIRSCHNER
Other 510(k) Applications for this Contact
Regulation Number
872.3070
More FDA Info for this Regulation Number
Classification Product Code
EJJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/08/2000
Decision Date
10/31/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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