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FDA 510(k) Application Details - K110897

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K110897
Device Name Powered Laser Surgical Instrument
Applicant SANDSTONE MEDICAL TECHNOLOGIES, LLC
105 CITATION COURT
HOMEWOOD, AL US
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Contact MARK ROHRER
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 03/31/2011
Decision Date 07/01/2011
Decision SE - Substantially Equivalent
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 N



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