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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K900515
Device Name MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S)
Original Applicant
7000 central ave. n.e.
minneapolis,  MN  55432
Original Contact lynn m nordstrom
Regulation Number870.1340
Classification Product Code
Date Received02/02/1990
Decision Date 08/23/1990
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No