510(k) K902531

EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL by G-C Intl. Corp. — Product Code EGW

K902531 is an FDA 510(k) premarket notification submitted by G-C Intl. Corp. for the device "EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL". The FDA issued a decision of Substantially Equivalent on July 13, 1990. The device falls under product code EGW (Dryer, Film, Radiographic), a Class II device regulated under 21 CFR 892.1900. G-C Intl. Corp. has at least 10 other 510(k) clearances on record.