510(k) K063367

45L CORE INSUFFLATOR, MODEL F114 by W.O.M. World of Medicine AG — Product Code HIF

K063367 is an FDA 510(k) premarket notification submitted by W.O.M. World of Medicine AG for the device "45L CORE INSUFFLATOR, MODEL F114". The FDA issued a decision of Substantially Equivalent on May 23, 2007. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. W.O.M. World of Medicine AG has at least 10 other 510(k) clearances on record.