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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 K062843
Device Name FOX SV PTA CATHETER
Applicant
Abbott Laboratories
400 Saginaw Dr.
Redwood,  CA  94063
Applicant Contact KATHRYN MARCHEL
Correspondent
Abbott Laboratories
400 Saginaw Dr.
Redwood,  CA  94063
Correspondent Contact KATHRYN MARCHEL
Regulation Number870.1250
Classification Product Code
LIT  
Date Received09/22/2006
Decision Date 10/17/2006
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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