510(k) K904085

ELLA BREAST FORM by Coloplast A/S — Product Code KCZ

K904085 is an FDA 510(k) premarket notification submitted by Coloplast A/S for the device "ELLA BREAST FORM". The FDA issued a decision of Substantially Equivalent on October 31, 1990. The device falls under product code KCZ (Prosthesis, Breast, External, Used With Adhesive), a Class I device regulated under 21 CFR 878.3800. Coloplast A/S has at least 10 other 510(k) clearances on record.