FDA 510(k) Application Details - K013500

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K013500
Device Name Activator, Ultraviolet, For Polymerization
Applicant KAVO AMERICA
340 EAST MAIN ST.
LAKE ZURICH, IL 60047 US
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Contact JENNIFER POTTALA
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 10/22/2001
Decision Date 01/14/2002
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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