510(k) K993653

MICRO-FRANCE TROCARS AND ACCESSORIES by Xomed, Inc. — Product Code HET

K993653 is an FDA 510(k) premarket notification submitted by Xomed, Inc. for the device "MICRO-FRANCE TROCARS AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on June 9, 2000. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Xomed, Inc. has at least 10 other 510(k) clearances on record.