FDA 510(k) Application Details - K070523

Device Classification Name

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510(K) Number K070523
Device Name MODIFICATION TO: VELSCOPE
Applicant LED DENTAL INC.
#201-15047 MARINE DR.
WHITE ROCK, BRITISH COLUMBIA V4B 1C5 CA
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Contact DAVID C MORGAN, PHD
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Regulation Number

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Classification Product Code NXV
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Date Received 02/23/2007
Decision Date 04/05/2007
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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