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FDA 510(k) Applications Submitted by KAREN MORTENSEN
FDA 510(k) Number
Submission Date
Device Name
Applicant
K060454
02/22/2006
TITAN GUIDEWIRE
LAKE REGION MFG., INC.
K080508
02/25/2008
MANDREL GUIDEWIRES OR M-WIRE
LAKE REGION MEDICAL
K040825
03/30/2004
LAKE REGION HYDROPHILIC GUIDEWIRE
LAKE REGION MFG., INC.
K041624
06/16/2004
PTCA STEERABLE HYDROPHILIC GUIDEWIRE
LAKE REGION MFG., INC.
K022813
08/26/2002
STEERABLE GUIDEWIRE
LAKE REGION MFG., INC.
K052347
08/29/2005
TITAN STEERABLE (PTCA) GUIDEWIRE
LAKE REGION MFG., INC.
K042338
08/30/2004
CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE
LAKE REGION MFG., INC.
K092965
09/25/2009
TRAILRUNNER GUIDEWIRES
LAKE REGION MFG., INC.
K033758
12/02/2003
HYDROPHILIC GUIDEWIRE
LAKE REGION MFG., INC.
K073655
12/26/2007
PEGASUS STEERABLE (PTCA) GUIDEWIRE
LAKE REGION MFG., INC.
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