FDA 510(k) Application Details - K241656

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K241656
Device Name Powered Laser Surgical Instrument
Applicant TermoSalud
Ata·lfo Friera Tarfe, 8
Gijon 33211 ES
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Contact Cristina Cifuentes
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 06/10/2024
Decision Date 08/12/2024
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 K241656


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