FDA 510(k) Application Details - K030146

Device Classification Name Laser, Dental, Soft Tissue

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510(K) Number K030146
Device Name Laser, Dental, Soft Tissue
Applicant KAVO AMERICA
340 EAST MAIN ST.
LAKE ZURICH, IL 60047 US
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Contact J0HN R FRANZ
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Regulation Number 878.4810

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Classification Product Code NVK
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Date Received 01/15/2003
Decision Date 08/03/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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