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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Oximeter, Fiber-Optic
510(k) Number K060093
Device Name PRESEP OLIGON OXIMETRY CATHETERS
Applicant
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact JASON SMITH
Correspondent
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Correspondent Contact JASON SMITH
Regulation Number870.1230
Classification Product Code
DQE  
Date Received01/12/2006
Decision Date 04/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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