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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K051519
Device Name FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)
Applicant
Abbott Laboratories (Perclose, Inc.)
400 Saginaw Dr.
Redwood,  CA  94063
Applicant Contact ANN E LEONARD
Correspondent
Abbott Laboratories (Perclose, Inc.)
400 Saginaw Dr.
Redwood,  CA  94063
Correspondent Contact ANN E LEONARD
Regulation Number870.1250
Classification Product Code
LIT  
Date Received06/08/2005
Decision Date 06/21/2005
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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