510(k) K982294

XOMED SILICONE PRE-FORM BLOCKS by Xomed, Inc. — Product Code KHJ

K982294 is an FDA 510(k) premarket notification submitted by Xomed, Inc. for the device "XOMED SILICONE PRE-FORM BLOCKS". The FDA issued a decision of Substantially Equivalent on September 18, 1998. The device falls under product code KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)), a Class II device regulated under 21 CFR 874.3620. Xomed, Inc. has at least 10 other 510(k) clearances on record.