510(k) K901307

PASSAGE AIRWAY SPLINT by Invotec International, Inc. — Product Code LYA

K901307 is an FDA 510(k) premarket notification submitted by Invotec International, Inc. for the device "PASSAGE AIRWAY SPLINT". The FDA issued a decision of Substantially Equivalent on June 14, 1990. The device falls under product code LYA (Splint, Intranasal Septal), a Class I device regulated under 21 CFR 874.4780. Invotec International, Inc. has at least 10 other 510(k) clearances on record.