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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 K120480
Device Name GORE(R) EMBOLIC FILTER
Applicant
W.L. Gore & Associates
4250 W. Kiltie Ln.
Flagstaff,  AZ  86001
Applicant Contact MICHELLE ANN WELLS
Correspondent
W.L. Gore & Associates
4250 W. Kiltie Ln.
Flagstaff,  AZ  86001
Correspondent Contact MICHELLE ANN WELLS
Regulation Number870.1250
Classification Product Code
NTE  
Date Received02/16/2012
Decision Date 03/16/2012
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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