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FDA 510(k) Application Details - K190007
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
Kathy Maynor
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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