FDA 510(k) Application Details - K040956

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K040956
Device Name Activator, Ultraviolet, For Polymerization
Applicant FIRST MEDICAL INFECTION CONTROL ASSOCIATES, INC.
3704-C BOREN DR.
GREENSBORO, NC 27407 US
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Contact DAVID SMALL
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 04/13/2004
Decision Date 06/14/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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