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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fab, Rhodamine, Antigen, Antiserum, Control
510(k) Number K013282
Device Name GORE INTRODUCER SHEATH
Applicant
W.L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
Flagstaff,  AZ  86002 -0500
Applicant Contact R. LARRY PRATT
Correspondent
W.L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
Flagstaff,  AZ  86002 -0500
Correspondent Contact R. LARRY PRATT
Regulation Number866.5520
Classification Product Code
DBY  
Date Received10/02/2001
Decision Date 12/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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