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FDA 510(k) Applications Submitted by FRED SWINDLER
FDA 510(k) Number
Submission Date
Device Name
Applicant
K092136
07/15/2009
PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5
ISORAY MEDICAL, INC.
K092458
08/11/2009
PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2
ISORAY MEDICAL, INC.
K970536
02/12/1997
MEDISYSTEMS TRANDUCER PROTECTOR
MEDISYSTEMS CORP.
K002372
08/04/2000
ACCESS ALERT GAUGE
MEDISYSTEMS CORP.
K132996
09/24/2013
CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS
ISORAY, INC
K062953
09/29/2006
MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE
MEDISYSTEMS CORP.
K111931
07/08/2011
GLIASITE RTS
ISORAY MEDICAL, INC.
K994306
12/21/1999
REVERSO
MEDISYSTEMS CORP.
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