FDA 510(k) Application Details - K061341

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K061341
Device Name Activator, Ultraviolet, For Polymerization
Applicant CAO GROUP, INC.
8683 SOUTH 700 WEST
SANDY, UT 84070 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 05/15/2006
Decision Date 06/12/2006
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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