510(k) K071281

UNIRING - ANNULOPLASTY RING WITH SIZERS by Peters Surgical — Product Code KRH

K071281 is an FDA 510(k) premarket notification submitted by Peters Surgical for the device "UNIRING - ANNULOPLASTY RING WITH SIZERS". The FDA issued a decision of Substantially Equivalent on August 3, 2007. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Peters Surgical has at least 6 other 510(k) clearances on record.