510(k) K970994

CORE AND COIL ASSEMBLY GUIDEWIRE by Lake Region Mfg., Inc. — Product Code EZB

K970994 is an FDA 510(k) premarket notification submitted by Lake Region Mfg., Inc. for the device "CORE AND COIL ASSEMBLY GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on March 25, 1997. The device falls under product code EZB (Stylet For Catheter, Gastro-Urology), a Class I device regulated under 21 CFR 876.5130. Lake Region Mfg., Inc. has at least 10 other 510(k) clearances on record.