FDA 510(k) Application Details - K962325

Device Classification Name Alloy, Gold-Based Noble Metal

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510(K) Number K962325
Device Name Alloy, Gold-Based Noble Metal
Applicant STERNGOLD/IMPLAMED
13794 N.W. 4TH ST., SUITE 209
SUNRISE, FL 33325 US
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Contact NICHOLAS J SAVARESE
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Regulation Number 872.3060

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Classification Product Code EJT
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Date Received 06/17/1996
Decision Date 07/24/1996
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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