FDA 510(k) Application Details - K980613

Device Classification Name Alloy, Gold-Based Noble Metal

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510(K) Number K980613
Device Name Alloy, Gold-Based Noble Metal
Applicant MICRO DENTAL LABORATORIES
6665 AMADOR PLAZA RD., #200
DUBLIN, CA 94568 US
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Contact NICOLAS E AZAR
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Regulation Number 872.3060

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Classification Product Code EJT
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Date Received 02/18/1998
Decision Date 03/09/1998
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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