FDA 510(k) Application Details - K051996

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K051996
Device Name Powered Laser Surgical Instrument
Applicant DIOMED, LTD.
CAMBRIDGE RESEARCH PARK
CAMBRIDGE CB5 9TE GB
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Contact TIM PHIPPS
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 07/25/2005
Decision Date 08/18/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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