510(k) K830884

SURGITEKS PERCUTANEOUS ANTEGRADE ALL - by Medical Engineering Corp. — Product Code FAD

K830884 is an FDA 510(k) premarket notification submitted by Medical Engineering Corp. for the device "SURGITEKS PERCUTANEOUS ANTEGRADE ALL -". The FDA issued a decision of Substantially Equivalent on May 9, 1983. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Medical Engineering Corp. has at least 10 other 510(k) clearances on record.