FDA 510(k) Application Details - K992707

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K992707
Device Name Powered Laser Surgical Instrument
Applicant AESCULAP-MEDITEC NORTH AMERICA
2525 MCGAW AVE.
IRVINE, CA 92623-9791 US
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Contact WILLIAM KELLEY
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 08/11/1999
Decision Date 10/19/1999
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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