510(k) K002755

NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE by T. Korossurgical Instruments Corp. — Product Code LRN

K002755 is an FDA 510(k) premarket notification submitted by T. Korossurgical Instruments Corp. for the device "NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE". The FDA issued a decision of Substantially Equivalent on December 4, 2000. The device falls under product code LRN (Wire, Surgical), a Class II device regulated under 21 CFR 888.3030. T. Korossurgical Instruments Corp. has at least 10 other 510(k) clearances on record.