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FDA 510(k) Application Details - K993175
Device Classification Name
Alloy, Gold-Based Noble Metal
More FDA Info for this Device
510(K) Number
K993175
Device Name
Alloy, Gold-Based Noble Metal
Applicant
JENERIC/PENTRON, INC.
53 NORTH PLAINS INDUSTRIAL RD.
P.O. BOX 724
WALLINGFORD, CT 06492-0724 US
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Contact
ANNMARIE TENERO
Other 510(k) Applications for this Contact
Regulation Number
872.3060
More FDA Info for this Regulation Number
Classification Product Code
EJT
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More FDA Info for this Product Code
Date Received
09/22/1999
Decision Date
10/26/1999
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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