510(k) K923394

MENLO CARE AQUASTENT SET by Menlo Care, Inc. — Product Code FAD

K923394 is an FDA 510(k) premarket notification submitted by Menlo Care, Inc. for the device "MENLO CARE AQUASTENT SET". The FDA issued a decision of Substantially Equivalent on November 16, 1993. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Menlo Care, Inc. has at least 10 other 510(k) clearances on record.