510(k) K904316

NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT by Coloplast Corp. — Product Code KCZ

K904316 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT". The FDA issued a decision of Substantially Equivalent on October 11, 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 Corp. has at least 10 other 510(k) clearances on record.