510(k) K842877

ABSOLUTE VINYL POLYSILOXANE IMPRESS by Coe Laboratories, Inc. — Product Code ELW

K842877 is an FDA 510(k) premarket notification submitted by Coe Laboratories, Inc. for the device "ABSOLUTE VINYL POLYSILOXANE IMPRESS". The FDA issued a decision of Substantially Equivalent on March 11, 1985. 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.