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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 K011968
Device Name STREERABLE PTCA GUIDEWIRE
Applicant
LAKE REGION MFG., INC.
340 LAKE HAZELTINE DR.
CHASKA,  MN  55318
Applicant Contact JEFF PUMPER
Correspondent
LAKE REGION MFG., INC.
340 LAKE HAZELTINE DR.
CHASKA,  MN  55318
Correspondent Contact JEFF PUMPER
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/25/2001
Decision Date 07/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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