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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name connector, tubing, dialysate
510(k) Number K771428
Device Name TENCKHOFF PERITONEAL TUBING ADAPT.
Original Applicant
QUINTON, INC.
Regulation Number876.5820
Classification Product Code
FKY  
Date Received08/01/1977
Decision Date 10/18/1977
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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