510(k) K020265

SERRALENE, MODEL CATALOG NO 1S by Serral, S.A. DE C.V. — Product Code GAW

K020265 is an FDA 510(k) premarket notification submitted by Serral, S.A. DE C.V. for the device "SERRALENE, MODEL CATALOG NO 1S". The FDA issued a decision of Substantially Equivalent on March 8, 2002. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Serral, S.A. DE C.V. has at least 5 other 510(k) clearances on record.