510(k) K812679

G-C FIT-CHECKER IMPRESSION MATERIAL by G-C Intl. Corp. — Product Code ELW

K812679 is an FDA 510(k) premarket notification submitted by G-C Intl. Corp. for the device "G-C FIT-CHECKER IMPRESSION MATERIAL". The FDA issued a decision of Substantially Equivalent on October 6, 1981. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. G-C Intl. Corp. has at least 10 other 510(k) clearances on record.