FDA 510(k) Application Details - K962592

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K962592
Device Name Powered Laser Surgical Instrument
Applicant ALCON LABORATORIES
6201 SOUTH FREEWAY
R7-14
FORT WORTH, TX 76134-2099 US
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Contact MARTIN A KAUFMAN
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 07/02/1996
Decision Date 09/23/1996
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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