FDA 510(k) Application Details - K060330

Device Classification Name Device, Caries Detection

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510(K) Number K060330
Device Name Device, Caries Detection
Applicant RONVIG DENTAL MFG. A/S
GL. VEJLEVEJ 59
DAUGAARD DK-8721 DK
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Contact ANNETTE RAVN NIELSEN
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Regulation Number 872.1740

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Classification Product Code LFC
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Date Received 02/09/2006
Decision Date 04/07/2006
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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