FDA 510(k) Application Details - K990670

Device Classification Name Alloy, Gold-Based Noble Metal

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510(K) Number K990670
Device Name Alloy, Gold-Based Noble Metal
Applicant C. HAFNER GMBH & CO.
THREE FIRST NATIONAL PLAZA
70 WEST MADISON ST. SUITE 3300
CHICAGO, IL 60602-4207 US
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Contact JOHN F LEMKER
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Regulation Number 872.3060

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Classification Product Code EJT
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Date Received 03/02/1999
Decision Date 04/02/1999
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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