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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 K051401
Device Name ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW 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 Received05/31/2005
Decision Date 11/30/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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