FDA 510(k) Application Details - K102083

Device Classification Name

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510(K) Number K102083
Device Name VELSCOPE VX
Applicant LED DENTAL INC.
235-5589 BYRNE ROAD
BURNABY , BC V5J 3J1 CA
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Contact DAVID MORGAN
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Regulation Number

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Classification Product Code NXV
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Date Received 07/26/2010
Decision Date 11/18/2010
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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