510(k) K801570

SHIELD DISP. PATIENTS PONCHO GOWNS by American Convertors Div., American Pharmaseal — Product Code FYB

K801570 is an FDA 510(k) premarket notification submitted by American Convertors Div., American Pharmaseal for the device "SHIELD DISP. PATIENTS PONCHO GOWNS". The FDA issued a decision of Substantially Equivalent on July 28, 1980. The device falls under product code FYB (Gown, Patient), a Class II device regulated under 21 CFR 878.4040. American Convertors Div., American Pharmaseal has at least 10 other 510(k) clearances on record.