FDA 510(k) Application Details - K960867

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K960867
Device Name Powered Laser Surgical Instrument
Applicant B.V. INTL. S.A.
89 BLVD.ETIENNE CLEMENTEL
CLERMONT FERRAND 63100 FR
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Contact CHRISTIAN CHABRIER
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 03/04/1996
Decision Date 05/14/1996
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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