510(k) K813634

ONE HANDED SHOE FASTENER by Fred Sammons, Inc. — Product Code ILD

K813634 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "ONE HANDED SHOE FASTENER". The FDA issued a decision of Substantially Equivalent on January 19, 1982. The device falls under product code ILD (Adaptor, Dressing), a Class I device regulated under 21 CFR 890.5050. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.