510(k) K020902

SERRALESTER by Serral, S.A. DE C.V. — Product Code GAT

K020902 is an FDA 510(k) premarket notification submitted by Serral, S.A. DE C.V. for the device "SERRALESTER". The FDA issued a decision of Substantially Equivalent on May 20, 2002. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Serral, S.A. DE C.V. has at least 5 other 510(k) clearances on record.