510(k) K911154

SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200 by Sun Medical, Inc. — Product Code FYD

K911154 is an FDA 510(k) premarket notification submitted by Sun Medical, Inc. for the device "SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200". The FDA issued a decision of Substantially Equivalent on July 26, 1991. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Sun Medical, Inc. has at least 3 other 510(k) clearances on record.