510(k) K060528

AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE by Aesculap, Inc. — Product Code GAR

K060528 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE". The FDA issued a decision of Substantially Equivalent on March 28, 2006. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Aesculap, Inc. has at least 10 other 510(k) clearances on record.