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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
Applicant
I-FLOW CORP.
20202 WINDROW DR.
LAKE FOREST,  CA  92630
Applicant Contact SHANE NOEHRE
Correspondent
I-FLOW CORP.
20202 WINDROW DR.
LAKE FOREST,  CA  92630
Correspondent 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 Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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