FDA 510(k) Application Details - K190007

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K190007
Device Name Powered Laser Surgical Instrument
Applicant Vydence Medical Industria E Comercio Ltda
Rua Aldo Germano Klein, 359
Cep: 13.573-470 - Caixa Postal 772
Ceat - Sao Carlos 13.573-470 BR
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Contact Kathy Maynor
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 01/02/2019
Decision Date 03/01/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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