FDA 510(k) Application Details - K963891

Device Classification Name Alloy, Metal, Base

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510(K) Number K963891
Device Name Alloy, Metal, Base
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 872.3710

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Classification Product Code EJH
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Date Received 09/26/1996
Decision Date 11/19/1996
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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