510(k) K850636

SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E by Fisher Scientific Co., LLC — Product Code KDX

K850636 is an FDA 510(k) premarket notification submitted by Fisher Scientific Co., LLC for the device "SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E". The FDA issued a decision of Substantially Equivalent on March 20, 1985. The device falls under product code KDX (Solution, Decalcifier, Acid Containing), a Class I device regulated under 21 CFR 864.4010. Fisher Scientific Co., LLC has at least 10 other 510(k) clearances on record.