510(k) K962683

SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR by Deknatel, Inc. — Product Code HIF

K962683 is an FDA 510(k) premarket notification submitted by Deknatel, Inc. for the device "SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR". The FDA issued a decision of Substantially Equivalent on January 10, 1997. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Deknatel, Inc. has at least 10 other 510(k) clearances on record.