510(k) K051848

SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 by Davol Inc., Sub. C. R. Bard, Inc. — Product Code GDW

K051848 is an FDA 510(k) premarket notification submitted by Davol Inc., Sub. C. R. Bard, Inc. for the device "SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079". The FDA issued a decision of Substantially Equivalent on August 11, 2005. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Davol Inc., Sub. C. R. Bard, Inc. has at least 10 other 510(k) clearances on record.