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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
Applicant
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Applicant Contact SARAH RIZK
Correspondent
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Correspondent Contact SARAH RIZK
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/21/2008
Decision Date 08/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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