FDA 510(k) Application Details - K031184

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K031184
Device Name Powered Laser Surgical Instrument
Applicant NEW STAR LASERS, INC.
9085 FOOTHILLS BLVD.
ROSEVILLE, CA 95747 US
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Contact DONALD V JOHNSON
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 04/15/2003
Decision Date 05/21/2003
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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