510(k) K930248

VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM by Crown Delta Corp. — Product Code ELW

K930248 is an FDA 510(k) premarket notification submitted by Crown Delta Corp. for the device "VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM". The FDA issued a decision of Substantially Equivalent on January 7, 1994. 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.