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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 K913517
Device Name ISOLATE INFUSION CATHETR SYSTEM
Original Applicant
LAKE REGION MFG., INC.
340 lake hazeltine dr.
chaska,  MN  55318
Original Contact paul kohl
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/07/1991
Decision Date 11/05/1991
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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