FDA 510(k) Application Details - K123169

Device Classification Name

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510(K) Number K123169
Device Name ORALID
Applicant FORWARD SCIENCE LLC
2511 WIND FALL LN
SUGAR LAND, TX 77479 US
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Contact BRIAN PIKKULA
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Regulation Number

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Classification Product Code NXV
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Date Received 10/09/2012
Decision Date 03/13/2013
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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