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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 K082304
Device Name ROLL-X GUIDEWIRE
Applicant
St Jude Medical
14901 Deveau Pl.
Minnetonka,  MN  55345 -2126
Applicant Contact JEFF STURM
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/13/2008
Decision Date 08/27/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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