510(k) K950457

CANNUAL AND TROCAR, SUPERPUBIC by Core Dynamics, Inc. — Product Code HET

K950457 is an FDA 510(k) premarket notification submitted by Core Dynamics, Inc. for the device "CANNUAL AND TROCAR, SUPERPUBIC". The FDA issued a decision of Substantially Equivalent on May 5, 1995. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Core Dynamics, Inc. has at least 10 other 510(k) clearances on record.