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FDA 510(k) Application Details - K960956
Device Classification Name
Alloy, Gold-Based Noble Metal
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510(K) Number
K960956
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
03/11/1996
Decision Date
05/29/1996
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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