510(k) K945701

SURGILENE(R) SUTURES by Davis & Geck, Inc. — Product Code GAW

K945701 is an FDA 510(k) premarket notification submitted by Davis & Geck, Inc. for the device "SURGILENE(R) SUTURES". The FDA issued a decision of SN on January 24, 1995. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Davis & Geck, Inc. has at least 10 other 510(k) clearances on record.