510(k) K781099

SURGICAL GOWNS AND DRAPES by Convertors — Product Code FYA

K781099 is an FDA 510(k) premarket notification submitted by Convertors for the device "SURGICAL GOWNS AND DRAPES". The FDA issued a decision of Substantially Equivalent on August 14, 1978. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Convertors has at least 9 other 510(k) clearances on record.