510(k) K914201

LM- LAP 10 HIGH FLOW INSUFFLATOR by Leisegang Medical, Inc. — Product Code HIF

K914201 is an FDA 510(k) premarket notification submitted by Leisegang Medical, Inc. for the device "LM- LAP 10 HIGH FLOW INSUFFLATOR". The FDA issued a decision of Substantially Equivalent on January 9, 1992. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Leisegang Medical, Inc. has at least 9 other 510(k) clearances on record.