FDA 510(k) Application Details - K992357

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K992357
Device Name Activator, Ultraviolet, For Polymerization
Applicant ICS OF NORTH AMERICA, INC.
10054 MESA RIDGE CT.
SAN DIEGO, CA 92121 US
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Contact ALAN A CREAMER
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 07/14/1999
Decision Date 08/30/1999
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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