510(k) K864786

PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT by Coloplast Corp. — Product Code GBI

K864786 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT". The FDA issued a decision of Substantially Equivalent on January 8, 1987. The device falls under product code GBI (Material, External Aesthetic Restoration, Used With Adhesive), a Class I device regulated under 21 CFR 878.3800. Coloplast Corp. has at least 10 other 510(k) clearances on record.