FDA 510(k) Application Details - K112031

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K112031
Device Name Powered Laser Surgical Instrument
Applicant ALMA LASERS, INC.
485 HALF DAY RD.
SUITE NO. 100
BUFFALO GROVE, IL 60089 US
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Contact ANNE WORDEN
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 07/15/2011
Decision Date 09/13/2011
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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