FDA 510(k) Application Details - K140481

Device Classification Name Varnish, Cavity

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510(K) Number K140481
Device Name Varnish, Cavity
Applicant COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855-1343 US
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Contact CHARLES IRELAND
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Regulation Number 872.3260

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Classification Product Code LBH
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Date Received 02/26/2014
Decision Date 06/05/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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