FDA 510(k) Application Details - K991996

Device Classification Name Resin, Denture, Relining, Repairing, Rebasing

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510(K) Number K991996
Device Name Resin, Denture, Relining, Repairing, Rebasing
Applicant DENPLUS, INC.
4235 BEACONSFIELD
MONTREAL, QUEBEC H4A 2H4 CA
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Contact SHUOJIA DONG
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Regulation Number 872.3760

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Classification Product Code EBI
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Date Received 06/14/1999
Decision Date 09/08/1999
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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