510(k) K111405

BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER, by Hangzhou Bever Medical Devices Co., Ltd. — Product Code GBM

K111405 is an FDA 510(k) premarket notification submitted by Hangzhou Bever Medical Devices Co., Ltd. for the device "BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,". The FDA issued a decision of Substantially Equivalent on February 13, 2012. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Hangzhou Bever Medical Devices Co., Ltd. has at least 3 other 510(k) clearances on record.