FDA 510(k) Application Details - K983266

Device Classification Name Post, Root Canal

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510(K) Number K983266
Device Name Post, Root Canal
Applicant JENERIC/PENTRON, INC.
53 NORTH PLAINS INDUSTRIAL RD.
P.O. BOX 724
WALLINGFORD, CT 06492-0724 US
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Contact MURRAY G GAMBERG
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Regulation Number 872.3810

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Classification Product Code ELR
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Date Received 09/17/1998
Decision Date 11/09/1998
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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