510(k) K143582

MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL by Resorba Medical GmbH — Product Code GAW

K143582 is an FDA 510(k) premarket notification submitted by Resorba Medical GmbH for the device "MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL". The FDA issued a decision of Substantially Equivalent on October 29, 2015. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Resorba Medical GmbH has at least 3 other 510(k) clearances on record.