510(k) K071218

PROXENON 350, MODEL 902XX by Welch Allyn, Inc. — Product Code FST

K071218 is an FDA 510(k) premarket notification submitted by Welch Allyn, Inc. for the device "PROXENON 350, MODEL 902XX". The FDA issued a decision of Substantially Equivalent on June 14, 2007. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. Welch Allyn, Inc. has at least 10 other 510(k) clearances on record.