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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oximeter
510(k) Number K083448
Device Name CABLE, TRANSDUCER, MODEL 2400GN
Original Applicant
CONMED CORPORATION
525 french rd.
utica,  NY  13502
Original Contact sarah rizk
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/21/2008
Decision Date 08/20/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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