FDA 510(k) Application Details - K000426

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K000426
Device Name Activator, Ultraviolet, For Polymerization
Applicant BISCO, INC.
1100 WEST IRVING PARK RD.
SCHAUMBURG, IL 60193 US
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Contact KATHRYN B PATTERSON
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 02/09/2000
Decision Date 04/12/2000
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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