FDA 510(k) Application Details - K241771

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K241771
Device Name Powered Laser Surgical Instrument
Applicant Medical San Ind·stria de Equipamentos MΘdicos Ltda.
Rua Alberto Muller, 1100 Block 20 - Rooms 404 and 406
Lajeado 95913528 BR
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Contact Francis Laion de Padua
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 06/20/2024
Decision Date 09/16/2024
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

FDA Source Information for K241771


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