FDA 510(k) Application Details - K110686

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K110686
Device Name Powered Laser Surgical Instrument
Applicant BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
M21
MARLBOROUGH, MA 01752 US
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Contact LAUREN ANDERSON
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 03/11/2011
Decision Date 03/28/2011
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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