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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 K052347
Device Name TITAN STEERABLE (PTCA) GUIDEWIRE
Applicant
Lake Region Mfg., Inc.
340 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact KAREN MORTENSEN
Correspondent
Lake Region Mfg., Inc.
340 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact KAREN MORTENSEN
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/29/2005
Decision Date 02/17/2006
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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