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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stylet for catheter, gastro-urology
510(k) Number K970994
Device Name CORE AND COIL ASSEMBLY GUIDEWIRE
Applicant
LAKE REGION MFG., INC.
340 LAKE HAZELTINE DR.
CHASKA,  MN  55318
Applicant Contact KIM AVES
Correspondent
LAKE REGION MFG., INC.
340 LAKE HAZELTINE DR.
CHASKA,  MN  55318
Correspondent Contact KIM AVES
Regulation Number876.5130
Classification Product Code
EZB  
Date Received03/19/1997
Decision Date 03/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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