510(k) K900808

RAPID AUTOMATIC PNEUMOPERITONEUM-I by Trek Medical Products, Inc. — Product Code HIF

K900808 is an FDA 510(k) premarket notification submitted by Trek Medical Products, Inc. for the device "RAPID AUTOMATIC PNEUMOPERITONEUM-I". The FDA issued a decision of Substantially Equivalent on September 19, 1990. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Trek Medical Products, Inc. has at least 7 other 510(k) clearances on record.