FDA 510(k) Application Details - K960403

Device Classification Name Alloy, Gold-Based Noble Metal

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510(K) Number K960403
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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Date Received 01/29/1996
Decision Date 02/26/1996
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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