FDA 510(k) Application Details - K952489

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K952489
Device Name Powered Laser Surgical Instrument
Applicant NEW STAR LASERS, INC.
1000 BURNETT AVE.
SUITE 450
CONCORD, CA 94520 US
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Contact DAVID W SCHLERF
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 05/30/1995
Decision Date 01/22/1996
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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