FDA 510(k) Application Details - K070378

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K070378
Device Name Powered Laser Surgical Instrument
Applicant ANGIODYNAMICS, INC.
603 QUEENSBURY AVE.
QUEENSBURY, NY 12804 US
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Contact TERI JUCKETT
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 02/08/2007
Decision Date 03/09/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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