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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K041762
Device Name FINISHING WIRE SUPPORTRAK
Applicant
Guidant Corporation
4100 Hamline Ave. N.
St Paul,  MN  55112 -5498
Applicant Contact JENNIFER TANG
Correspondent
Guidant Corporation
4100 Hamline Ave. N.
St Paul,  MN  55112 -5498
Correspondent Contact JENNIFER TANG
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/30/2004
Decision Date 08/06/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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