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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K030618
Device Name WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE
Applicant
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD.
WINSTON-SALEM,  NC  27105
Applicant Contact MARGARET J POSNER
Correspondent
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD.
WINSTON-SALEM,  NC  27105
Correspondent Contact MARGARET J POSNER
Regulation Number868.5150
Classification Product Code
BSP  
Date Received02/26/2003
Decision Date 05/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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