510(k) K050610

SALUTE FIXATION SYSTEM by Davol Inc., Sub. C. R. Bard, Inc. — Product Code GDW

K050610 is an FDA 510(k) premarket notification submitted by Davol Inc., Sub. C. R. Bard, Inc. for the device "SALUTE FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 25, 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.