510(k) K834343

COMFEEL POWDER by Coloplast A/S — Product Code KOZ

K834343 is an FDA 510(k) premarket notification submitted by Coloplast A/S for the device "COMFEEL POWDER". The FDA issued a decision of Substantially Equivalent on November 8, 1984. The device falls under product code KOZ (Beads, Hydrophilic, For Wound Exudate Absorption), a Class I device regulated under 21 CFR 878.4018. Coloplast A/S has at least 10 other 510(k) clearances on record.