510(k) K830786

DISIMETRIC RELEASE OF INSTRANETICS RAD by American Convertors Div., American Pharmaseal — Product Code KOA

K830786 is an FDA 510(k) premarket notification submitted by American Convertors Div., American Pharmaseal for the device "DISIMETRIC RELEASE OF INSTRANETICS RAD". The FDA issued a decision of Substantially Equivalent on May 18, 1983. The device falls under product code KOA (Surgical Instruments, G-U, Manual (And Accessories)), a Class I device regulated under 21 CFR 876.4730. American Convertors Div., American Pharmaseal has at least 10 other 510(k) clearances on record.