510(k) K894281

FIRST IMPRESSION WITH CHLORHEXIDINE by Coe Laboratories, Inc. — Product Code ELW

K894281 is an FDA 510(k) premarket notification submitted by Coe Laboratories, Inc. for the device "FIRST IMPRESSION WITH CHLORHEXIDINE". The FDA issued a decision of Substantially Equivalent on September 26, 1989. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Coe Laboratories, Inc. has at least 10 other 510(k) clearances on record.