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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 K941229
Device Name ONTRAC STEERABLE GUIDEWIRE
Applicant
Lake Region Mfg., Inc.
340 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact CARL BEAURLINE
Correspondent
Lake Region Mfg., Inc.
340 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact CARL BEAURLINE
Regulation Number870.1330
Classification Product Code
DQX  
Date Received03/15/1994
Decision Date 05/12/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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