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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
Predetermined Change
Control Plan Authorized		 No
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