FDA 510(k) Application Details - K150585

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K150585
Device Name Activator, Ultraviolet, For Polymerization
Applicant CAO GROUP, INC.
4628 WEST SKYHAWK DRIVE
WEST JORDAN, UT 84084 US
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Contact Robert K Larsen
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 03/09/2015
Decision Date 12/31/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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