FDA 510(k) Application Details - K103461

Device Classification Name Varnish, Cavity

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510(K) Number K103461
Device Name Varnish, Cavity
Applicant COLGATE-PALMOLIVE CO.
909 RIVER RD.
PISCATAWAY, NJ 08855-1343 US
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Contact CHARLES P IRELAND
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Regulation Number 872.3260

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Classification Product Code LBH
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Date Received 11/24/2010
Decision Date 09/13/2011
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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