510(k) K801380

CROWN DELTA SILICONE IMPRESSION MATERIAL by Crown Delta Corp. — Product Code ELW

K801380 is an FDA 510(k) premarket notification submitted by Crown Delta Corp. for the device "CROWN DELTA SILICONE IMPRESSION MATERIAL". The FDA issued a decision of Substantially Equivalent on July 8, 1980. 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.