510(k) K904231

MODEL OSP, SANDHILL AMS by Sandhill Scientific, Inc. — Product Code FAD

K904231 is an FDA 510(k) premarket notification submitted by Sandhill Scientific, Inc. for the device "MODEL OSP, SANDHILL AMS". The FDA issued a decision of Substantially Equivalent on January 2, 1991. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Sandhill Scientific, Inc. has at least 10 other 510(k) clearances on record.