510(k) K863830

CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM by Coloplast A/S — Product Code EZQ

K863830 is an FDA 510(k) premarket notification submitted by Coloplast A/S for the device "CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 16, 1986. The device falls under product code EZQ (Pouch, Colostomy), a Class I device regulated under 21 CFR 876.5900. Coloplast A/S has at least 10 other 510(k) clearances on record.