510(k) K851480

VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRW by Vygon Corp. — Product Code LAE

K851480 is an FDA 510(k) premarket notification submitted by Vygon Corp. for the device "VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRW". The FDA issued a decision of Substantially Equivalent on May 7, 1985. The device falls under product code LAE (High Pressure Liquid Chromatography, Codeine), a Class II device regulated under 21 CFR 862.3270. Vygon Corp. has at least 10 other 510(k) clearances on record.