510(k) K062540

NASOPORE EAR, MODELS ND04, ND05 by Polyganics B.V., — Product Code KCN

K062540 is an FDA 510(k) premarket notification submitted by Polyganics B.V., for the device "NASOPORE EAR, MODELS ND04, ND05". The FDA issued a decision of Substantially Equivalent on October 18, 2006. The device falls under product code KCN (Ear Wick), a Class I device regulated under 21 CFR 874.5220. Polyganics B.V., has at least 8 other 510(k) clearances on record.