FDA 510(k) Application Details - K041767

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K041767
Device Name Powered Laser Surgical Instrument
Applicant BRUCE J. SAND M.D.
638 LINDERO CANYON RD. #507
OAK PARK, CA 91377 US
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Contact BRUCE J SAND, M.D.
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 06/30/2004
Decision Date 09/30/2004
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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