510(k) K881636

CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) by Coloplast A/S — Product Code EXB

K881636 is an FDA 510(k) premarket notification submitted by Coloplast A/S for the device "CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)". The FDA issued a decision of Substantially Equivalent on July 13, 1988. 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.