510(k) K940336

CERTI HEAT INSTANT HEAT COMPRESS by Certified Safety Mfg., Inc. — Product Code IMD

K940336 is an FDA 510(k) premarket notification submitted by Certified Safety Mfg., Inc. for the device "CERTI HEAT INSTANT HEAT COMPRESS". The FDA issued a decision of Substantially Equivalent on March 7, 1994. The device falls under product code IMD (Pack, Hot Or Cold, Disposable), a Class I device regulated under 21 CFR 890.5710. Certified Safety Mfg., Inc. has at least 10 other 510(k) clearances on record.