510(k) K904965

SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4 by Smith & Nephew Equipment Group — Product Code FSY

K904965 is an FDA 510(k) premarket notification submitted by Smith & Nephew Equipment Group for the device "SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4". The FDA issued a decision of Substantially Equivalent on January 16, 1991. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Smith & Nephew Equipment Group has at least 1 other 510(k) clearance on record.