510(k) K040232

LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999 by Lsi Solutions — Product Code GAT

K040232 is an FDA 510(k) premarket notification submitted by Lsi Solutions for the device "LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999". The FDA issued a decision of Substantially Equivalent on March 1, 2004. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Lsi Solutions has at least 10 other 510(k) clearances on record.