510(k) K770119

I.V. LOK TM by Jelco Laboratories — Product Code KMK

K770119 is an FDA 510(k) premarket notification submitted by Jelco Laboratories for the device "I.V. LOK TM". The FDA issued a decision of Substantially Equivalent on March 14, 1977. The device falls under product code KMK (Device, Intravascular Catheter Securement), a Class I device regulated under 21 CFR 880.5210. Jelco Laboratories has at least 10 other 510(k) clearances on record.