510(k) K153089

'cottony' II TAPE, PLEDGETS by Teleflexmedical, Inc. — Product Code GAT

K153089 is an FDA 510(k) premarket notification submitted by Teleflexmedical, Inc. for the device "'cottony' II TAPE, PLEDGETS". The FDA issued a decision of Substantially Equivalent on August 12, 2016. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Teleflexmedical, Inc. has at least 10 other 510(k) clearances on record.