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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, dialysate delivery, central multiple patient
510(k) Number K820769
Device Name GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL
Original Applicant
GAMBRO, INC.
Regulation Number876.5820
Classification Product Code
FKQ  
Date Received03/22/1982
Decision Date 04/16/1982
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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