FDA 510(k) Application Details - K024046

Device Classification Name Coating, Filling Material, Resin

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510(K) Number K024046
Device Name Coating, Filling Material, Resin
Applicant BISCO, INC.
1100 WEST IRVING PARK RD.
SCHAUMBURG, IL 60193 US
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Contact STEPHEN SMITH
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Regulation Number 872.3310

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Classification Product Code EBD
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Date Received 12/06/2002
Decision Date 02/06/2003
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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