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FDA 510(k) Applications Submitted by IRINA KULINETS
FDA 510(k) Number
Submission Date
Device Name
Applicant
K050541
03/02/2005
OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY
OMNIGUIDE COMMUNICATIONS, INC.
K121127
04/13/2012
SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS
CYNOSURE, INC.
K121346
05/04/2012
PICOSURE WORKSTATION
CYNOSURE, INC.
K061909
07/06/2006
HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00
OMNIGUIDE, INC.
K062126
07/26/2006
EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135
BIOSPHERE MEDICAL, INC.
K123407
11/05/2012
CELLULAZE LASER
CYNOSURE, INC.
K123971
12/26/2012
CYNOSURE 1064NM DIODE LASER
CYNOSURE, INC.
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