FDA 510(k) Application Details - K092951

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K092951
Device Name Activator, Ultraviolet, For Polymerization
Applicant MECTRON S.P.A.
15, VIA LORETO
CARASCO 16042 IT
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Contact ROGER GRAY
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 09/24/2009
Decision Date 12/07/2009
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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