FDA 510(k) Application Details - K024374

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K024374
Device Name Activator, Ultraviolet, For Polymerization
Applicant LOKKI LASERS MEDICAUX
344 ANNABELLE POINT RD.
CENTERVILLE, MA 02632-2402 US
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Contact HILLARD W WELCH
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 12/31/2002
Decision Date 03/10/2003
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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