510(k) K243001

Sterile Water USP and Sterile 0.9% Normal Saline USP by Laboratorios Biogalenic S.A. DE C.V. — Product Code FRO

K243001 is an FDA 510(k) premarket notification submitted by Laboratorios Biogalenic S.A. DE C.V. for the device "Sterile Water USP and Sterile 0.9% Normal Saline USP". The FDA issued a decision of Substantially Equivalent on March 6, 2025. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Laboratorios Biogalenic S.A. DE C.V. has at least 2 other 510(k) clearances on record.