FDA 510(k) Application Details - K131760

Device Classification Name Agent, Polishing, Abrasive, Oral Cavity

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510(K) Number K131760
Device Name Agent, Polishing, Abrasive, Oral Cavity
Applicant WHIP-MIX CORP.
361 FARMINGTON AVE.
LOUISVILLE, KY 40217 US
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Contact JOHN P WATERS
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Regulation Number 872.6030

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Classification Product Code EJR
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Date Received 06/17/2013
Decision Date 03/26/2014
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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