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FDA 510(k) Application Details - K981244
Device Classification Name
Alloy, Gold-Based Noble Metal
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510(K) Number
K981244
Device Name
Alloy, Gold-Based Noble Metal
Applicant
J.F. JELENKO & CO., INC.
99 BUSINESS PARK DR.
ARMONK, NY 10504 US
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Contact
TRIDIB DASGUPTA
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Regulation Number
872.3060
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Classification Product Code
EJT
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More FDA Info for this Product Code
Date Received
04/06/1998
Decision Date
08/13/1998
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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