510(k) K842924

ORANGE G, 1% by E K Ind., Inc. — Product Code HZH

K842924 is an FDA 510(k) premarket notification submitted by E K Ind., Inc. for the device "ORANGE G, 1%". The FDA issued a decision of Substantially Equivalent on September 7, 1984. The device falls under product code HZH (Orange G), a Class I device regulated under 21 CFR 864.1850. E K Ind., Inc. has at least 10 other 510(k) clearances on record.