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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, conduction, anesthetic
510(k) Number K043456
Device Name MODIFICATION TO SOAKER CATHETER
Original Applicant
I-FLOW CORP.
20202 windrow dr.
lake forest,  CA  92630
Original Contact shane noehre
Regulation Number868.5120
Classification Product Code
BSO  
Date Received12/15/2004
Decision Date 01/11/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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