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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K021608
Device Name SMITHWICK CAROTID SHUNT
Applicant
Implantable Devices
P.O. Box 270882
Tampa,  FL  33688
Applicant Contact WILLIAM E MCPHERSON
Correspondent
Implantable Devices
P.O. Box 270882
Tampa,  FL  33688
Correspondent Contact WILLIAM E MCPHERSON
Regulation Number870.4450
Classification Product Code
DXC  
Date Received05/16/2002
Decision Date 10/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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