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FDA 510(k) Application Details - K984164
Device Classification Name
Alloy, Metal, Base
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510(K) Number
K984164
Device Name
Alloy, Metal, Base
Applicant
JELENKO CO.
99 BUSINESS PARK DR.
ARMONK, NY 10504 US
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Contact
TRIDIB DASGUPTA
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Regulation Number
872.3710
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Classification Product Code
EJH
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Date Received
11/20/1998
Decision Date
12/29/1998
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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