510(k) K896630

SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM by Atos Medical AB — Product Code KAM

K896630 is an FDA 510(k) premarket notification submitted by Atos Medical AB for the device "SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 6, 1990. The device falls under product code KAM (Cannula, Sinus), a Class I device regulated under 21 CFR 878.4800. Atos Medical AB has at least 10 other 510(k) clearances on record.