510(k) K910783

SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M by Smith & Nephew Equipment Group — Product Code BWN

K910783 is an FDA 510(k) premarket notification submitted by Smith & Nephew Equipment Group for the device "SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M". The FDA issued a decision of Substantially Equivalent on April 2, 1991. The device falls under product code BWN (Table And Attachments, Operating-Room), a Class I device regulated under 21 CFR 878.4950. Smith & Nephew Equipment Group has at least 1 other 510(k) clearance on record.