FDA 510(k) Application Details - K983161

Device Classification Name Post, Root Canal

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510(K) Number K983161
Device Name Post, Root Canal
Applicant SABRE-K LTD.
GOLF ROAD, HALE ALTRINCHAM
CHESHIRE WA 15 8AH GB
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Contact STEVEN BUCKLEY
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Regulation Number 872.3810

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Classification Product Code ELR
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Date Received 09/09/1998
Decision Date 09/30/1998
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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