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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporary Carotid Catheter For Embolic Capture
510(k) Number K123156
Device Name GORE FLOW REVERSAL SYSTEM MODEL GFRS073
Applicant
W.L. Gore & Associates, Inc.
32360 N N. Valley Pkwy.
Phoenix,  AZ  85085
Applicant Contact SHARON ALEXANDER
Correspondent
W.L. Gore & Associates, Inc.
32360 N N. Valley Pkwy.
Phoenix,  AZ  85085
Correspondent Contact SHARON ALEXANDER
Regulation Number870.1250
Classification Product Code
NTE  
Date Received10/09/2012
Decision Date 12/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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