FDA 510(k) Application Details - K041614

Device Classification Name Light, Operating, Dental

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510(K) Number K041614
Device Name Light, Operating, Dental
Applicant ADDENT, INC.
43 MIRY BROOK RD.
DANBURY, CT 06810 US
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Contact JOSHUA FRIEDMAN
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Regulation Number 872.4630

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Classification Product Code EAZ
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Date Received 06/15/2004
Decision Date 04/04/2005
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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