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FDA 510(k) Applications Submitted by ANNE M KULIS
FDA 510(k) Number
Submission Date
Device Name
Applicant
K971034
03/21/1997
USCI MAINSTAY GUIDING CATHETER
C.R. BARD, INC.
K971265
04/04/1997
VIKING DIAGNOSTIC ELECTRODE CATHETER
C.R. BARD, INC.
K041705
06/23/2004
RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2
OMNISONICS MEDICAL TECHNOLOGIES
K071762
06/29/2007
OMNIWAVE ENDOVASCULAR SYSTEM
OMNISONICS MEDICAL TECHNOLOGIES
K052428
09/02/2005
RESOLUTION ENDOVASCULAR SYSTEM
OMNISONICS MEDICAL TECHNOLOGIES
K083335
11/12/2008
MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM
OMNISONICS MEDICAL TECHNOLOGIES
K034025
12/29/2003
NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC
NMT MEDICAL, INC.
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