510(k) K821637

WIRE-FOAM MP FLEXION SPRING by Fred Sammons, Inc. — Product Code ILH

K821637 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "WIRE-FOAM MP FLEXION SPRING". The FDA issued a decision of Substantially Equivalent on June 11, 1982. The device falls under product code ILH (Splint, Hand, And Components), a Class I device regulated under 21 CFR 890.3475. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.