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FDA 510(k) Applications Submitted by ANDREW LEE
FDA 510(k) Number
Submission Date
Device Name
Applicant
K961118
03/20/1996
MAXIM PF MODELS 033-581/033-590
TELECTRONICS PACING SYSTEMS, INC.
K012512
08/06/2001
SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM
RADIANT MEDICAL
K042388
09/02/2004
RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE
RADIANT MEDICAL
K024327
12/26/2002
SETPOINT ENDOVASCULAR TEMPERATURE PROBE
RADIANT MEDICAL
K050644
03/14/2005
VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT
VANCOUVER BIOTECH LTD.
K093444
11/05/2009
EXAPACS
MEDINCOM TECHNOLOGY CORP
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