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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K850829
Device Name WIRE, GUIDE, CATHETER
Applicant
LAKE REGION MFG., INC.
340 LAKE HAZELTINE DR.
CHASKA,  MN  55318
Applicant Contact JIM KLOSTERMAN
Correspondent
LAKE REGION MFG., INC.
340 LAKE HAZELTINE DR.
CHASKA,  MN  55318
Correspondent Contact JIM KLOSTERMAN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/25/1985
Decision Date 06/26/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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