510(k) K771428

TENCKHOFF PERITONEAL TUBING ADAPT. by Quinton, Inc. — Product Code FKY

K771428 is an FDA 510(k) premarket notification submitted by Quinton, Inc. for the device "TENCKHOFF PERITONEAL TUBING ADAPT.". The FDA issued a decision of Substantially Equivalent on October 18, 1977. The device falls under product code FKY (Connector, Tubing, Dialysate), a Class II device regulated under 21 CFR 876.5820. Quinton, Inc. has at least 10 other 510(k) clearances on record.