FDA 510(k) Application Details - K980568

Device Classification Name Cement, Dental

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510(K) Number K980568
Device Name Cement, Dental
Applicant CENTRIX, INC.
770 RIVER RD.
SHELTON, CT 06484-5458 US
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Contact JOHN DISCKO
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Regulation Number 872.3275

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Classification Product Code EMA
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Date Received 02/09/1998
Decision Date 04/30/1998
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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