FDA 510(k) Application Details - K990902

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K990902
Device Name Powered Laser Surgical Instrument
Applicant MEDICAL LASER TECHNOLOGIES LTD.
UNIT 15,BELLEKNOWES INDUSTRIAL
ESTATE
INVERKEITHING,FIFE KY11 1HY GB
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Contact DAVID HAMILTON
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 03/18/1999
Decision Date 05/27/1999
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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