510(k) K890820

LOCKING WIRE GUIDE STYLET by Medical Engineering and Development Institute — Product Code GAD

K890820 is an FDA 510(k) premarket notification submitted by Medical Engineering and Development Institute for the device "LOCKING WIRE GUIDE STYLET". The FDA issued a decision of Substantially Equivalent on March 22, 1989. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Medical Engineering and Development Institute has at least 5 other 510(k) clearances on record.