FDA 510(k) Application Details - K030959

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K030959
Device Name Powered Laser Surgical Instrument
Applicant LASER PERIPHERALS LLC.
1000 BOONE AVENUE NORTH
SUITE 300
GOLDEN VALLEY, MN 55427 US
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Contact JEFFREY M STEIN
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 03/27/2003
Decision Date 04/25/2003
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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