510(k) K904819

SHUR-LOCK ICE WRAP SYSTEM by Conco Medical Co. — Product Code IMD

K904819 is an FDA 510(k) premarket notification submitted by Conco Medical Co. for the device "SHUR-LOCK ICE WRAP SYSTEM". The FDA issued a decision of Substantially Equivalent on December 6, 1990. The device falls under product code IMD (Pack, Hot Or Cold, Disposable), a Class I device regulated under 21 CFR 890.5710. Conco Medical Co. has at least 10 other 510(k) clearances on record.