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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 K063234
Device Name ON-Q INTRODUCERS
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 Received10/25/2006
Decision Date 11/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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