510(k) K812554

TOMAC STERILE DISP. LAP SPONGE by American Convertors Div., American Pharmaseal — Product Code GDY

K812554 is an FDA 510(k) premarket notification submitted by American Convertors Div., American Pharmaseal for the device "TOMAC STERILE DISP. LAP SPONGE". The FDA issued a decision of Substantially Equivalent on September 24, 1981. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. American Convertors Div., American Pharmaseal has at least 10 other 510(k) clearances on record.