FDA 510(k) Applications for Medical Device Product Code "FSW"
(Light, Surgical, Endoscopic)

FDA 510(k) Number Applicant Device Name Decision Date
K013511 ACULUX, INC. XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) 02/01/2002
K022989 GENZYME BIOSURGERY RADLITE TISSUE RETRACTOR SYSTEM 11/25/2002


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