FDA 510(k) Application Details - K000805

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K000805
Device Name Powered Laser Surgical Instrument
Applicant KAVO AMERICA
340 EAST MAIN ST.
LAKE ZURICH, IL 60047 US
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Contact JOHN FRANZ
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 03/13/2000
Decision Date 05/04/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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