FDA 510(k) Application Details - K052310

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K052310
Device Name Powered Laser Surgical Instrument
Applicant UNIPHY ELEKTROMEDIZIN GMBH & CO. KG
6A PASWEG
BILZEN 3740 BE
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Contact NICO BEUN
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 08/24/2005
Decision Date 03/15/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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