510(k) K861070

COLOPLAST CONVEX RING by Coloplast A/S — Product Code EXB

K861070 is an FDA 510(k) premarket notification submitted by Coloplast A/S for the device "COLOPLAST CONVEX RING". The FDA issued a decision of Substantially Equivalent on June 16, 1986. The device falls under product code EXB (Collector, Ostomy), a Class I device regulated under 21 CFR 876.5900. Coloplast A/S has at least 10 other 510(k) clearances on record.