510(k) K872745

VINYL POLYSILOXANE IMPRESSION SYSTEM by Crown Delta Corp. — Product Code ELW

K872745 is an FDA 510(k) premarket notification submitted by Crown Delta Corp. for the device "VINYL POLYSILOXANE IMPRESSION SYSTEM". The FDA issued a decision of Substantially Equivalent on July 21, 1987. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Crown Delta Corp. has at least 10 other 510(k) clearances on record.