FDA 510(k) Applications for Medical Device Product Code "MYU"
(Accessory,Barium Sulfate,Methyl Methacrylate For Cranioplasty)

FDA 510(k) Number Applicant Device Name Decision Date
K002063 BRYAN CORP. BIOTRACE, MODEL 1730 08/10/2000
K032388 Cardinal Health BONE CEMENT RADIO-OPACIFIER 10/31/2003
K991893 PARALLAX MEDICAL, INC. PARALLAX TRACER RADIOPAQUE PARTICLES 08/13/1999
K023445 PARALLAX MEDICAL, INC. TRACERS BONE CEMENT OPACIFIER 03/11/2003
K033230 PARALLAX MEDICAL, INC. TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA 12/12/2003
K024359 VISTA SCIENTIFIC, LLC VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 08/08/2003


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