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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K802378
Device Name QUICK PRIME LINES, #'S BPL-12, BPL-48 &
Original Applicant
Regulation Number870.4210
Classification Product Code
Date Received09/30/1980
Decision Date 10/10/1980
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No