510(k) K813052

ULTRACAST WATERLESS SYNTHETIC RESIN CAST by Zimmer, Inc. — Product Code ITG

K813052 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "ULTRACAST WATERLESS SYNTHETIC RESIN CAST". The FDA issued a decision of Substantially Equivalent on February 4, 1982. The device falls under product code ITG (Bandage, Cast), a Class I device regulated under 21 CFR 890.3025. Zimmer, Inc. has at least 10 other 510(k) clearances on record.