510(k) K812344

HEEL OR ELBOW PROTECTOR by Fred Sammons, Inc. — Product Code FMP

K812344 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "HEEL OR ELBOW PROTECTOR". The FDA issued a decision of Substantially Equivalent on September 11, 1981. The device falls under product code FMP (Protector, Skin Pressure), a Class I device regulated under 21 CFR 880.6450. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.